**ExhibitNo. 10.4**

 

**Confidential Materials omitted and filed separately with theSecurities and Exchange Commission. Asterisks denote omissions.**

 

**GENOTYPINGSERVICES AGREEMENT**

 

This GENOTYPING SERVICES AGREEMENT (the “Agreement”)is made as of the 11 day of March 2003 (the “Effective Date”), by and betweenGenaissance Pharmaceuticals, Inc., with its principal place of business at FiveScience 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 forProposal for the provision of Genotyping Services to support its servicecontract with the Perinatology Research Branch (PRB) of the National Instituteof Child Health and Human Development (NICHD);

 

WHEREAS, on January 9, 2003 Genaissance submitted aProposal for Wayne State University in Response to the RFP – GenotypingServices;

 

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

 

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

 

2.                                       Genaissanceagrees to perform the Genotyping Services, and WSU agrees to pay for theperformance of same, pursuant to the provisions set forth in the attacheddocuments.

 

IN WITNESS WHEREOF, the parties have caused their dulyauthorized officer to execute and deliver this Agreement as of the date firstset forth above.

 

GENAISSANCE PHARMACEUTICALS, INC.

 
| By:    | /s/ Gerald F. Vovis                                    |   |
|--------|--------------------------------------------------------|--------|
| Name:  | Gerald F. Vovis, Ph.D.                                 |
| Title: | Executive Vice President and Chief Technology  Officer |
|        |                                                        |        |  |

 

WAYNE STATE UNIVERSITY

 
| By:    | /s/ John L. Davis                 |   |
|--------|-----------------------------------|--------|
| Name:  | John L. Davis                     |   |
|   |
| Title: | Senior Vice President for Finance |   |
|   | and Administration 3/20/03        |   |
|        |                                   |        |  |  |  |

 

1

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Table of Contents 

 
| **Document**                                                                                                                             |   | **Originating Party** |   | **Last Revision  Date/Party** |
|------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------|--------|-------------------------------|
|                                                                                                                                     |   |                  |   |                          |
| Wayne State  University  Request for Proposal for  Providing Genotyping Services for 2002/2003                                           |   | WSU                   |   | December 16,  2002            |
|                                                                                                                                     |   |                  |   |                          |
| Addendum One (1)  to Request for Proposal for Genotyping Services December 16, 2002                                                      |   | WSU                   |   | December 30,  2002            |
|                                                                                                                                     |   |                  |   |                          |
| Addendum Two (2)  to Request for Proposal for Genotyping Services December 16, 2002                                                      |   | WSU                   |   | January 07, 2003              |
|                                                                                                                                     |   |                  |   |                          |
| Proposal for  Wayne State University in Response to RFP – Genotyping Services                                                       |   | GNSC                  |   | January 9, 2003               |
|                                                                                                                                     |   |                  |   |                          |
| Addendum to  Schedule C of Proposal                                                                                                      |   | GNSC                  |   | March 11, 2003  WSU and GNSC  |
|                                                                                                                                     |   |                  |   |                          |
| Addendum to  Addendum 1 (Terms and Conditions) of Proposal                                                                               |   | WSU                   |   | February 19,  2003/GNSC       |
|                                                                                                                                     |   |                  |   |                          |
| Replacement of  Addendum 2 (License Agreement) of Proposal                                                                               |   | GNSC                  |   | March 10, 2003  WSU and GNSC  |
|                                                                                                                                     |   |                  |   |                          |
| Addendum 3 to  Proposal, Additional Services*Comparison of Cohorts  Sequence Finishing and Quality Control  Analysis of Candidate Genes* |   | GNSC                  |   | March 10, 2003  WSU and GNSC  |
|                                                                                                                                     |   |                  |   |                          |
| WSU Project Seq  Tracking*Time line for sequencing and quality  control  analysis of 200 candidate genes*                                |   | GNSC                  |   | March 7,  2003/GNSC           |
|                                                                                                                                     |   |                  |   |                          |
| WSU Project  Tracking*Time line for genotyping 4,000 DNA  samples with an average of [**] SNPs from  each of 200 candidate genes*        |   | GNSC                  |   | January 28,  2003/GNSC        |
|                                                                                                                                     |   |                  |   |                          |
| Press Release                                                                                                                            |   | GNSC                  |   | March 10, 2003  WSU and GNSC  |

 

2

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|                                 | **[Attachment  1]**         |
|--------------------------------------|-----------------------------|
|                                 |                        |
| **WAYNE  STATE UNIVERSITY**          | **Purchasing Department**   |
| **Division  of Business Operations** | **Detroit, Michigan 48202** |
|                                 | **(313) 577-3757**          |
|                                 | **FAX (313) 577-3747**      |
|                                 |                        |
|                                 | December 16, 2002           |

 

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

 

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

 

We have enclosedour Request for Proposal and Specifications for your review andconsideration.  If you are interested inparticipating in this process, please note the proposal due date and place asfollows:

 

**Thursday,January 9, 2003 - 4:00 p.m.**Wayne State UniversityAttn:  Kimberly Tomaszewski, SeniorBuyerRFP - Genotyping Services5700 Cass Avenue, 4th Floor - Suite 4200 AABDetroit, MI 48202

 

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

 
|   | Sincerely,            |   |
|--------|-----------------------|--------|
|   |                  |   |
|   | /s/ Kim               |   |
|   |                  |
|   | Kimberly  Tomaszewski |
|   | Senior Buyer          |

** **

**3**

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**WAYNE STATE UNIVERSITY**

** **

**REQUEST FOR PROPOSAL**

** **

**AND SPECIFICATIONS FOR**

** **

**GENOTYPING SERVICES**

 

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

** **

**Wayne State UniversityPurchasing Department**

** **

**RFP - Genotyping Services**

** **

**December 16, 2002**

 

4

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**WAYNESTATE UNIVERSITY**

** **

**REQUESTFOR PROPOSALFOR GENOTYPING SERVICES**

 
|                                             | **Note**                                                      |
|--------------------------------------------------|---------------------------------------------------------------|
|                                             |                                                          |
| I.                                               | INTRODUCTION                                                  |
| II.                                              | INFORMATION FOR VENDOR                                        |
| III.                                             | GENERAL  REQUIREMENTS AND GUIDELINES                          |
| IV.                                              | STATEMENT / SCOPE OF WORK                                     |
| V.                                               | Additional  Instructions To VENDORS — Business Proposals |
| VI.                                              | Vendor Qualifications                                         |
| VII.                                             | SUMMARY  OF GENERAL MANDATORY REQUIREMENTS                    |
|                                             |                                                          |
| SCHEDULES                                        |
|                                             |                                                          | Schedules A1 | Proposal  Certification |
|                                             |                                                          | Schedules  A2 | Non-Collusion  Affidavit |
|                                             |                                                          | Schedule B | Insurance  Requirements |
|                                             |                                                          | Schedule C | Price Schedule |
|                                             |                                                          | Schedule D | Summary  Questionnaire |
|                                             |                                                          | Schedule E | Representations,  Certifications and Other Statement of Offerors or Quoters (vendors) |
|                                             |                                                          |   |   |
| EXHIBITS TO BE SUBMITTED WITH VENDOR PROPOSAL(S) |
|                                             |                                                          |   |   |
|                                             | Vendor  Exhibit 1                                             | Exceptions/Restricted  Services |
|                                             | Vendor  Exhibit 2                                             | Profile/Experience/References |
|                                             | Vendor  Exhibit 3                                             | Service Plan |
|                                             | Vendor  Exhibit 4                                             | Vendor  Qualifications |
|                                             | Vendor  Exhibit 5                                             | Small Business  Subcontracting Plan |

 

5

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**NOTE**

 

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

 

6

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I.                                         **INTRODUCTION**

 

## **A.**                                   Wayne State University(hereafter referred to as UNIVERSITY or WSU) is a comprehensive university withapproximately 31,000 students.  Thismakes the University the third largest in the state.  The graduate school, with nearly 13,000 students, is the largestin Michigan.  There are 14 schools andcolleges.  The University offers 355major subject areas, 128 bachelor, 136 master, and 61 different doctoraldegrees plus 30 different certificate, specialist and professionalprograms.  There are over 202,000 alumniof the UNIVERSITY, many of whom have assumed leadership positions in the communitiesof southeastern Michigan.  Many successfuldoctors and health care professionals, lawyers, engineers, educators, businessexecutives and managers, civic leaders, and community members obtained theireducation at WSU.

 

In fiscal year 2001, the UNIVERSITY had revenues andyear 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 the3,600 accredited universities in the U.S., this select group offers a broadrange of baccalaureate programs while demonstrating a commitment to graduateeducation and a significant capacity for research.

 

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

## ** **

## **B.**                                     The Purchasing (PD)Department of the UNIVERSITY is soliciting proposals from qualifiedprofessional organizations, hereafter referred to as VENDOR(s), who specializein providing Genotyping Services of superior quality at competitive pricing,under the direction of the UNIVERSITY’S Perinatology Research Branch of theNational Institute (NICHD), as described in the Statement of Work section ofthe Request For Proposal (RFP).

 

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

 

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

 

7

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

 

VENDOR selected shall have an excellent track recordfor handling service programs of our size and scope and shall provide theUNIVERSITY with a top priority commitment.

## ** **

## **C.**                                     The UNIVERSITY reservesthe right to accept, reject, modify, and/or negotiate any and all proposalsreceived in conjunction with the RFP.  Itreserves the right to waive any defect or informality in the Proposals on thebasis of what it considers to be in its best interests.  Any proposal which the UNIVERSITY determinesto be incomplete, conditional, obscure, or has irregularities of any kind, maybe rejected.  The UNIVERSITY reserves theright to award to the firm, or firms, which in its sole judgment, will bestserve its long-term interest.

## ** **

## **D.**                                    This RFP in no mannerobligates the UNIVERSITY to the eventual purchase of any products or servicesdescribed, implied, or which may be proposed, until confirmed by writtenagreement, and may be terminated by the UNIVERSITY without penalty orobligation at any time prior to the signing of an Agreement.

## ** **

## **E.**                                      Expenses for developingand presenting proposals shall be the entire responsibility of the VENDOR andshall not be chargeable to the UNIVERSITY. All supporting documentation and manuals submitted with this proposalwill become the property of the UNIVERSITY unless otherwise requested by theVENDOR, in writing, at the time of submission, and agreed to, in writing, bythe UNIVERSITY.

## ** **

## **F.**                                      All questions concerningthis 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 toKenneth Doherty, C.P.M., Associate Director, at (313) 577-3756, Email,ac0578@wayne.edu.  Under nocircumstances may a VENDOR contact other individuals at the UNIVERSITY, todiscuss any aspect of this RFP, unless expressly authorized by the Purchasing Departmentto 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 thisRFP carefully, in that the degree of interrelationship between sections ishigh.  Clause headings appearing in thisRFP have been inserted for convenience and ready reference.

 

8

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They do not purport to define, limit or extend thescope 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 arequired feature of this RFP.  In thosecases where mandatory requirements are stated, material failure to meet thoserequirements could result in disqualification of the VENDOR’S response.  Any deviation or exception from RFPspecifications 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.**                                     Calendarof 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 UNIVERSITYwill make every effort to adhere to the above schedule.  It is subject however, to timeextensions.  This would be in the eventthat further clarification of responses or terms of contract are in the bestinterest of the UNIVERSITY and in the event the UNIVERSITY requires more timeto 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 heldto have examined the UNIVERSITY requirements outlined in the Statement of Workand Technical Information sections, and satisfied itself as to the existingconditions under which it will be obligated to perform in accordance withspecifications of this RFP.

 

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

 

9

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VENDOR has full knowledge of all of the existingconditions, 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 supportingdocumentation shall be delivered in a sealed envelope or container to theUNIVERSITY Purchasing Department.  Thespecific format for responses is detailed in **SectionII E**(below).  Proposals and **Schedule D**, Price Schedule must be signedand the authority of the individual signing must be stated thereon.  For the VENDOR’S convenience, the PriceSchedule and Appendices will be provided on diskette using Microsoft Excelversion 97.  VENDORS are encouraged touse 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 PurchasingDepartment is **4:00 p.m. on January 9, 2003**.  Date and time will be stamped on theproposals by the Purchasing Department. Proposals received after that time will not be accepted.  VENDORS submitting proposals after thedue date and time will be required to retrieve the unopened proposals.

## ** **

## **E.**                                      Proposal Format

 

Proposals are to be submitted as a booklet or innotebook form with appropriate indices. Each proposal should be prepared simply and economically, providing astraightforward concise description of the VENDOR’S service, approach andability to meet the UNIVERSITY’S needs as stated in this RFP.  Schedules and Exhibits must clearly identifyand 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

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

 

F.                                      **Proposal Evaluation**

 

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

 

**PrimaryConsiderations**

 

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

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

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

 

**AdditionalConsiderations**

 

•                  Ability to meetall mandatory requirements and specifications of this RFP;

•                  Cost ofServices; Compensation and Fees; (Schedule C);

•                  FinancialStrength of the Vendor;

•                  ProposalDocumentation / Presentation;

•                  VENDOR’SExperience (Exhibit 2);

•                  VENDORProfiles/References; (Exhibit 2);

•                  VENDOR ServicePlan; (Exhibit 3);

•                  VENDORQualifications; (Exhibit 4).

 

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

 

VENDOR proposals will beevaluated by an evaluation team consisting of members of the UNIVERSITY’SPurchasing Department and the PRB.  Apreliminary screening will be used to identify competitive VENDORS who have metthe mandatory requirements.  ThePurchasing Department may subsequently request selected VENDORS to make apresentation at a set time and date, to clarify information provided in theproposals.  Final consideration,evaluation, and recommendation may be made at this point.  However, the UNIVERSITY reserves the rightto take additional time for reference review, site visits and/or proposalnegotiations.

 

11

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2.**                                      **Toqualify for evaluation, a VENDOR’S proposal must be responsive, must have beensubmitted on time and must materially satisfy all mandatory requirementsidentified throughout the RFP.  To beconsidered responsive, a proposal must be reasonable and substantially conformin the judgment of the UNIVERSITY to all of the specified requirements in theRFP.  Any deviation from requirementsindicated herein must be stated in the proposal specifically under the category“Restricted Services”, and clearly identified as **Exhibit 1**.  Otherwiseit will be considered that proposals are in strict compliance with allrequirements, and any successful VENDOR will be held responsible therefor.

 

3.**                                      **Ifthere are portions of any proposal the UNIVERSITY finds unacceptable orotherwise in need of clarification or revision, the UNIVERSITY reserves theright to negotiate with any or all VENDORS. Should the outcome of evaluations result in a recommendation, anyresultant contract shall be subject to the approval of the UNIVERSITY’S GeneralCounsel and be approved and signed by the appropriate UNIVERSITYrepresentative.

 

4.**                                      **Afternotification of acceptance of proposal and the signing of a resultant agreementand/or Purchase Order, the successful VENDOR will be expected to establish andbe in a position to provide Genotyping Services commencing on or before January24, 2003.

 

## **G.**                                     Vendor Profile, Experience and References 

 

1.**                                      **VendorProfile should include:

 

VENDOR is required toprovide both financial and organizational data that demonstrate the size, scopeand capability of the Company to handle the UNIVERSITY’S specific requirementsspecified in this RFP.

 

VENDOR is required toidentify all organizational components and other Companies or Organizationswith which it is affiliated.  Includecomponent and other company addresses.  Explainany company relationships that could be construed to be a conflict of interestin doing business with the UNIVERSITY now or in the future.  Indicate any significant past or pendinglawsuits or malpractice claims against the VENDOR.

 

VENDOR must submitindependently audited financial statements **(onecopy only)**including its statement of statement of revenues andexpenses and year-end balance statements for at least the past threeyears.  Include most recently availableinterim statements.  Such financialinformation will be treated in strict confidence.  Financial information should be submitted, under separate cover,directly to:

 

12

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Joan M. Gossman, C.P.M.

Wayne State University-RFP Genotyping Services

Purchasing Department

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

Detroit, MI 48202

 

VENDORS who would liketheir financial statements returned to them must include a self addressedenvelope marked “Confidential” with their financial statement.  If VENDOR has already submitted financialstatements within **120 days**of thisRFP, VENDOR may indicate the RFP date and RFP title in the VENDORS cover letterinstead of resubmitting these statements.

 

2.**                                      **Experience

 

The successful VENDORshall be an organization that has an excellent record as a licensed externalprovider of the Genotyping Services in the type and scope detailed in thisRFP.  Accordingly, VENDORS are to statein their proposals their qualifications to meet the RFP specifications in termsof past and current experience with the same or similar requirements.  VENDORS are to focus on experiences withorganizations having needs similar to that of the UNIVERSITY.

 

3.**                                      **References

 

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

 

The references suppliedshould 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 ofthe product or services provided including the approximate annual aggregatedollar volume involved.

 

III.                                 **GENERAL REQUIREMENTS AND GUIDELINES**

 

## **A.**                                   Terms and Conditions

 

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

 

13

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

 

## **B.**                                     Governing Law (Michigan)

 

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

## ** **

## **C.**                                     Non-Discrimination

 

The parties agree that in the performance of anycontract they shall not discriminate in any manner on the basis of race, creed,color, national origin, age, religion, sex, sexual orientation, marital statusor handicap protected by law.  Suchaction shall include, but is not limited to the following: employment,upgrading, demotion, transfer, recruitment or recruitment advertising; layoffor termination; rates of pay or other forms of compensation.  By submitting a proposal, VENDORS certifythat they will conform to the provisions of the Federal Civil Rights Action of1964, as amended.

 

## **D.**                                    Immigration Reform andControl Act of 1986

 

By submitting a proposal, the VENDORS certify thatthey do not and will not during the performance of this contract employ illegalalien workers or otherwise violate the provisions of the federal ImmigrationReform and Control Act of 1986.

 

## **E.**                                      Debarment Status

 

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

 

## **F.**                                      Indemnification and HoldHarmless

 

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

## ** **

## **G.**                                     (This Section DeliberatelyLeft Blank)

## ** **

## **H.**                                    Early Termination

 

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

 

14

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1.                                       Defaultof VENDOR

 

It shall be considered adefault whenever the VENDOR shall:

 

a.***                                      ***Disregardor violate material provisions of the contract documents or UNIVERSITYinstructions, or fail to execute the work according to the agreed upon scheduleof completion and/or time of completion specified, including extensionsthereof, or fail to reach agreed upon performance results.

 

b.***                                     ***Declarebankruptcy, become insolvent, or assign company assets for the benefit ofcreditors.

 

2.                                       Convenienceof the UNIVERSITY

 

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

 

Note: Any contract cancellation notice shall notrelieve the VENDOR of the obligation to deliver and/or perform prior to theeffective date of cancellation.

 

## **I.**                                         Cancellation of Contractby VENDOR

 

VENDOR must provide a minimum of ninety (90) dayswritten notice of cancellation of contract to the UNIVERSITY regardless of thereason for said termination.  Suchnotification must be sent to:

 

Joan M. Gossman, C.P.M.Wayne State University-RFP Genotyping Services - 2002/03Purchasing Department5700 Cass Avenue, Suite 4200, A.A.B.Detroit, MI 48202

 

## **J.**                                        Non-Assignment

 

The agreement shall be between the UNIVERSITY and theVENDOR and the VENDOR shall neither assign nor delegate the agreement, itsrights or obligations, or any of its terms without the express writtenpermission of the UNIVERSITY.  Thispertains 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 andservices in accordance with specifications set forth in this RFP.  Rates and other requested data must bestated on or in the exact format of **ScheduleC, Price Schedule**.  VENDORshall be responsible for all errors and omissions.  In the event of a discrepancy between

 

15

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

 

**PleaseNote: VENDORS must respond using Schedule C. Failure to do so may result in disqualification of your Proposal.  VENDORS shall be responsible for all errorsand omissions.**

 

## **L.**                                      Pricing Variances

 

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

 

## **M.**                                 Civil Rights Requirements

 

All VENDORS must be in compliance with the directivesof the Michigan Department of Civil Rights. *In addition, Vendors are required tocomply with all federal equal opportunity requirements, as stated in ScheduleE; Representations, Certifications and Other Statement of Offerors or Quoters(VENDORS).  Vendors must complete theSchedule 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 apart of the VENDOR’S proposal.

 

## **O.**                                    Vendor Payment/BillingTerms

 

Payments of invoices will be made thirty (30) daysafter receipt and approval of invoice, by the UNIVERSITY Project Manager, foreach month completed.

 

## **P.**                                      Entire Agreement

 

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

 

## **Q.**                                    Severability

 

It is understood and agreed that if any part, term, orprovision of this agreement is by the courts held to be illegal or in conflictwith any law of the State of Michigan, the validity of the remaining portionsor provisions shall be construed and enforced as if the Agreement did notcontain the particular part, term, or provision held to be invalid.

 

16

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## **R.**                                     Modification of Service

 

The UNIVERSITY reserves the right to modify theservices during the course of the contract, with concurrence of theVENDOR.  Any changes in pricing andrates proposed by the VENDOR resulting from such changes are subject toacceptance by the UNIVERSITY.

 

In the event prices andrates cannot be negotiated to the satisfaction of both parties, the contractmay be subject to competitive bidding based upon the new specifications.

 

## **S.**                                      Publicity

 

VENDORS must refrain from giving any reference to thisproject, whether in the form of press releases, brochures, photographiccoverage, or verbal announcements, without specific written approval from theUNIVERSITY.

 

## **T.**                                     Independent Contractor

 

The VENDOR agrees that in all respects itsrelationship with the UNIVERSITY will be that of an independent contractor, andthat it will not act or represent that it is acting as an agent of theUNIVERSITY or incur any obligation on the part of the UNIVERSITY withoutwritten authority of the UNIVERSITY.

 

## **U.**                                    Confidentiality

 

Proposals could be subject to public review after thecontracts have been awarded.  VENDORSresponding to this proposal are cautioned not to include any proprietaryinformation as part of their proposal unless such proprietary information iscarefully identified as such in writing, and the UNIVERSITY accepts, inwriting, the information as proprietary.

 

## **V.**                                     Insurance Requirements

 

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

 

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Questions on insurance requirements should be directedto 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 acertified minority firm.  TheUniversity, in accordance with guidelines from the Michigan Minority BusinessDevelopment Counsel (MMBDC), considers a minority firm as one that is at least51% owned, operated, and controlled by a minority, or in case of apublicly-owned business, at least 51% of the stock must be owned by a minority.  Such minorities include, but are not limitedto:

 

| • | African  Americans |   | • | Hispanic  Americans |
|--------|--------------------|--------|--------|---------------------|
| • | Asian Americans    |   | • | Native Americans    |
| • | Eskimos            |   | • | Aleuts              |

 

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

 

1.                                       Reporting

 

The selected firm willidentify and fairly consider minority firms for subcontracting opportunitieswhen qualified firms are available to perform a given task in performing forthe 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 tothe award of the contract.  Only theselected VEDNOR will be asked to submit this plan.  The form can be downloaded at shown onhttp://www.ogam2000.com/smallbus/6%2D1.htm. In addition, the selected VENDOR must submit a quarterly minoritybusiness report to the UNIVERSITY Purchasing Department by the 15th of themonth following each calendar quarter; specifically the months of April, July,October, and January.  Such reportsshould 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

 

 

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2.                                       ReportDetail

 

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

•                  Minorityfirm’s name, address, and phone number with which the VENDOR has contractedover the-specified quarterly period

•                  Contactperson at the minority firm who has knowledge of the specified information

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

•                  Totalamount paid to the minority firm as it relates to the UNIVERSITY account

 

## **X.**                                    Ownership of Documents

 

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

 

IV.                                 **STATEMENT/ SCOPE OF WORK**

 

## **A.**                                   General Description of theRequired Objectives and Desired Results

 

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

 

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

 

A body of evidence now indicates that severalobstetrical syndromes are.  clusteredwithin families suggesting the presence of heritable risk factors.  Moreover, recent evidence derived from DNAlinkage studies indicates that a precise genetic locus is linked topre-eclampsia.  Genetic associationstudies of candidate genes also indicate that certain polymorphisms areassociated with a predisposition for these complications and, in some cases,protection.

 

Perinatal morbidity and mortality are largelydetermined 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 congenitalanomalies account for over 95% of infant mortality (death before the age ofone).

 

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Although obstetrical complications have beenrecognized since antiquity, it is now apparent that they are not discretedisorders and are now collectively referred by the term “the great obstetricalsyndromes”.  The features of thesesyndromes are: 1) multiple etiologies; 2) chronicity; 3) the clinicalmanifestations (i.e., hypertension, PTL, rupture of membranes or reduced fetalgrowth) are adaptive in nature; 4) symptomatic treatment of the specificsyndrome is ineffective in reducing perinatal morbidity; and 5) clinicalpresentation depends upon genetic (fetal and/or maternal) and environmentalinteractions.

 

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

 

The PRB located at WSU has begun to use microarraytechnology to identify candidate genes and is now ready to test whether geneticfactors predispose to adverse pregnancy outcome, especially in minoritypopulations.

 

## **B.**                                     Technical Requirements

 

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

 

##### * *

##### *(a)*                                  General requirements:

 

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

 

 

20

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

 

3.                                       TheVENDOR 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 sampleswith multiple genotypes per sample, including a description of the specificsoftware packages to be used.  Themanagement of electronic data, computer hardware and software, and storage ofinformation generated from the contract should be harmonized with existing WSUinformation technology capabilities wherever feasible.

 

##### *(b)*                                 The VENDOR shall providethe following services:

 

1.                                       Providethe PRB investigators designated by WSU with haplotype and allele frequencyinformation for polymorphisms in the candidate genes from different ethnicgroups, and assist in identifying suitable polymorphisms for the study.

 

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

 

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

 

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

 

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

 

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

 

21

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##### *(c)*                                  WSU will provide:

 

1.             Overall technical direction and an outline of the scopeof 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 willnotify the VENDOR beforehand about the shipment of samples).

 

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

 

## **C.**                                     Intellectual Property andPublications

 

##### *(a)*                                  This is a servicecontract, not a research contract. Therefore, no data are to be published without the advance consent andapproval of WSU, and the funding organization, the NICHD.

 

##### *(b)*                                 The VENDOR shall assert nointellectual property rights with regard to genotyping data derived from theexperiments described in this document in section B.  If the VENDOR makes additional public domain assays availableduring the term of this Contract, WSU will be allowed to include the use ofthese new assays in this Contract

 

## **D.**                                    Reporting Requirements

 

##### *(a)*                                  The VENDOR shall informthe designated investigators at WSU via e-mail upon receipt of samplesverifying number of samples received, ID numbers and condition

 

##### *(b)*                                 The VENDOR shall send areport on results of genotyping, as specified in the Statement of Work, todesignated investigators at WSU within 5 working days of completion

 

##### *(c)*                                  The VENDOR shall send aquarterly detailed progress report of the analysis for each set of samples,including methods used, number of genotypes assayed, and the data for eachsample as specified in the Statement of Work

 

##### *(d)*                                 The VENDOR shall informWSU about quality control experiments performed with each assay.  If the quality control experiments are notwithin the VENDOR’s specifications, the VENDOR will notify WSU and consult withthe WSU.  The VENDOR should provide theresults within 40-45 working days from the receipt of PEP-samples from WSU.

 

##### *(e)*                                  A copy of the lettertransmitting any of the above items should be sent to the Project Manager,Services in Support of the Perinatology Research

 

22

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##### *Branch, Wayne State University, C.S.  Mott Center for Human Growth andDevelopment, 275 E.  Hancock, Detroit,MI 48201*

 

V.                                     **AdditionalInstructions To VENDORS – Business Proposals**

 

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

 

## **A.**                                   General Instructions

 

You must provide the following information on thefirst 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 thisproposal, we grant Wayne State University and authorized representative(s) theright to examine, at any time before award, those records, which include books,documents, accounting procedures and practices, and other data, regardless oftype and form or whether such supporting information is specifically referencedor included in the proposal as the basis for pricing, that will permit anadequate evaluation of the proposed price.

 

#### ***e.***                                       Date of submission

 

#### ***f.***                                         Name, title and signature of authorizedrepresentative

 

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

 

If any of the prices proposed are based on commercialactivities or are on the GSA schedule, please provide us with a catalog pricelist 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 themaximum quantity will be 10,000 DNA samples.

 

## **B.**                                     Past PerformanceInformation

 

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

 

23

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currently in process that are similar in nature to thesolicitation.  Include the followinginformation 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 performanceunder existing and prior contracts for similar products or services.  WSU is not required to contact allreferences provided by the offeror. Also, references other than those identified by the offeror may becontacted by WSU to obtain additional information that will be used in theevaluation of the offeror’s past performance.

 

VI.                                 **VendorQualifications**

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

VII.                             **SUMMARYOF GENERAL MANDATORY REQUIREMENTS**

 

## **A.**                                   Original clearly marked assuch 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 fordelivery of proposals to the Purchasing Department by 4:00 p.m., January9, 2003.

 

## **D.**                                    Proposals remain in effecta minimum of 120 days.  A statement tothis effect must be contained in the VENDOR’S cover letter.

 

## **E.**                                      Any deviation from the RFPrequirements must be stated in proposal, under “Restricted Services”.  Otherwise, proposal is held to be in strictcompliance with this RFP.

 

## **F.**                                      VENDOR profile, statementof experience, qualifications, comparative financial statements, and minimum ofthree qualified references, are required information for the purpose ofconsideration in this RFP process.

 

## **G.**                                     VENDOR’S Quotation, ScheduleC, is to becompleted by VENDOR, signed and submitted with Proposal.  Vendors are encouraged to use the disksprovided, and return a completed copy with their proposal.

 

## **H.**                                    VENDOR agrees to alltechnical and general requirements and guidelines, additional generalprovisions, VENDOR service plan specifications, and all other specificationsand terms specified in the RFP.

 

## **I.**                                         Vendor must complete theProposal Certification and Non-Collusion Affidavit (Schedules Al and A2) asspecified, sign and submit as a part of the proposal.

 

## **J.**                                        Vendor must completeSchedule E, Representations, Certifications and Other Statements of Offerors orQuoters (VENDORS).

 

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## **K.**                                    Provide Certificates ofInsurance or other evidence that insurance is in place, which meets or exceedsrequirements outlined in Schedule B.

 

## **L.**                                      Ability to commence fullservice by January 24, 2003.

 

**FAILURETO MEET THE MANDATORY REQUIREMENTS MAY RESULT INDISQUALIFICATION OF YOUR PROPOSAL**

 

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**Schedule A.1**

 

**PROPOSAL CERTIFICATION**

 

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

 

**RESPONSETO WAYNE STATE UNIVERSITY**

**REQUESTFOR PROPOSAL FOR**

**PROVIDINGGENOTYPING SERVICES FOR 2002 / 2003**

**DATED:December 16, 2002**

** **

**ANDTO ANY AMENDMENTS, THERETO**

 

The undersigned, duly authorized to represent the persons, firms andcorporations joining and participating in the submission of this Proposalstates that the Proposal contained herein is complete and is in strictcompliance with the requirements of the subject Request for Proposal datedDecember 16, 2002, except as noted in Exhibit 1, the “RestrictedServices/Exceptions to RFP” section of the Proposal.  If there are no modifications, deviations or exceptions, statesame 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 deliveredor mailed by first class or certified mail, with proper postage, prepaid, tothe Subject VENDOR at the following address:

 
| Company Name: |   |    |
|---------------|--------|---------|
|          |   |    |
| Address:      |   |    |
|          |   |    |
|          |   |    |
|          |   |    |
| ATTN:         |   |    |
|          |   |    |
|          |   |    |
| Tax Payer ID: |   |    |
|          |   |    |
|          |   |    |
| Submitted by: |   |    |
|          |   |    |
|          |   |    |
| Signature     |   |    |
|          |   |    |
|          |   |    |
| Typed Name    |   |    |
|          |   |    |
|          |   |    |
|          |   |    |   |   |
|          |   | (Title) |   | (Date) |

 

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**NON-COLLUSION AFFIDAVIT**

 

The undersigned, duly authorized to represent the persons; firms andcorporations joining and participating in the submission of the foregoingProposal (such persons, firms and corporations hereinafter being referred to asthe “VENDOR”), being duly sworn, on his or her oath, states that to the best ofhis or her belief and knowledge no person, firm or corporation, nor any personduly representing the same joining and participating in the submission of theforegoing Proposal, has directly or indirectly entered into any agreement orarrangement with any other VENDORS, or with any official of the UNIVERSITY orany employee thereof, or any person, firm or corporation under contract withthe UNIVERSITY whereby the VENDOR, in order to induce acceptance of theforegoing Proposal by said UNIVERSITY, has paid or is to pay to any otherVENDOR or to any of the aforementioned persons anything of value whatever, andthat the VENDOR has not, directly or indirectly entered into any arrangement oragreement with any other VENDOR or VENDORS which tends to or does lessen ordestroy free competition in the letting of the contract sought for by theforegoing 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 orperson, in connection with this solicitation, to submit a collusive or shambid, to refrain from bidding, to manipulate or ascertain the price(s) of otherproposers or potential proposers, or to obtain through any unlawful act anadvantage over other proposers or the college.

 

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

 

**CONFLICTOF INTEREST**

 

The undersigned proposer and each person signing on behalf of theproposer certifies, and in the case of a sole proprietorship, partnership orcorporation, each party thereto certifies as to its own organization, underpenalty of perjury, that to the best of their knowledge and belief, no memberof the UNIVERSITY, nor any employee, or person, whose salary is payable inwhole or in part by the UNIVERSITY, has a direct or indirect financial interestin the award of this Proposal, or in the services to which this Proposalrelates, or in any of the profits, real or potential, thereof, except as notedotherwise 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:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |   |                                                                                                                                                                                                      |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     |        |                                                                                                                                                                                                           |        |  |  |  |

 

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**Schedule B**

 

**INSURANCE REQUIREMENTS**

 

                                                                                                   atits sole expense, shall cause to be issued and maintained in full effect forthe term of this agreement, insurance as set forth hereunder:

 

**GeneralRequirements**

 
| **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                                          |

 

**MaximumAcceptable Deductibles**

 
| **Type of Insurance**               |   | **Deductible** |   |
|-------------------------------------|--------|----------------|--------|
|                                |   |           |   |
| Comprehensive  General Liability    |   | $              | 250    |   |
| Comprehensive  Automobile Liability |   | 0              |   |
| Workers’  Compensation         |   | 0              |   |
|                                     |        |                |        |  |

 

**Coverages**

 

1.               All liabilitypolicies must be written on an occurrence form.

 

2.               Comprehensivegeneral liability includes, but is not limited to: consumption or use ofproducts, existence of equipment or machines on location, and contractualobligations to customers.

 

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

 

**Certificatesof Insurance**

 

1.               Certificates ofInsurance stating the minimum required coverages must be forwarded to theOffice of Risk Management to be verified and, authenticated with the agent and/orinsurance company.

 

2.               Certificates shouldcontain a statement from the insurer that, for this contract, the care, custodyor control exclusion is waived.

 

3.               Certificates shallbe issued on a ACORD form or one containing the equivalent wording, and requiregiving WSU a thirty (30) day written notice of cancellation or material changeprior to the normal expiration of coverage.

 

4.               Revisedcertificates must be forwarded to the Office of Risk Management thirty (30)days prior to the expiration of any insurance coverage listed on the originalcertificate.

 

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**PRICESCHEDULE C**

 

**SUMMARYOF QUOTED RATES**

** **

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**SCHEDULE C****-Price ScheduleReply to Wayne State University Request for ProposalFor Genotyping Services**

 
| **NAME OF TEST** |   | **UNIT PRICE** |   | **ESTIMATED  QUANTITY** |   | **TOTAL** |
|------------------|--------|----------------|--------|-------------------------|--------|-----------|
|             |   |           |   |                    |   |      |
|             |   |           |   |                    |   |      |
|             |   |           |   |                    |   |      |
|             |   |           |   |                    |   |      |
|             |   |           |   |                    |   |      |

 

**Alternateproposals for this solicitation are not acceptable”.**

 

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

 
| Company Name:    |   |                                                     |   |                                                          |
|------------------|--------|----------------------------------------------------------|--------|---------------------------------------------------------------|
|             |   |                                                     |   |                                                          |
| Company Address: |   |                                                     |   |                                                          |
|             |   |                                                     |   |                                                          |
|             |   |                                                     |   |                                                          |
|             |   |                                                     |   |                                                          |
| Submitted by:    |   |                                                     |   |                                                          |
|             |   |                                                     |   |                                                          |
| Signature        |   |                                                     |   |                                                          |
|             |   |                                                     |   |                                                          |
| Typed Name       |   |                                                     |   |                                                          |
|             |   | (Title)                                                  |   | (Date)                                                        |
|             |   |                                                     |   |                                                          |
| Phone            |   | (         ) |   | fax  (         ) |

 

31

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**Schedule D****- Summary Questionnaire**

 
|   |                                                                                                  |   | **YES** |            | **ALTERNATIVE** |
|--------|-------------------------------------------------------------------------------------------------------|--------|---------|-----------------|-----------------|
| 1.     | Can your company  provide services on or before **January 24,  2003**?                           |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 2.     | Have you  provided three (3) references with specific contact names and phone numbers?’          |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 3.     | Did your company  provide a certificate of insurance to meet or exceed all our minimum  requirements? |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 4.     | Did your company  provide the required Proposal Certification and Non– Collusion Affidavit?      |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 5.     | Did your company  complete and provide the Summary Price Schedule C?                                  |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 6.     | Did your company  complete and provide Schedule E, Statement of Representations and  Certifications?  |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 7.     | Did your company  agree to guarantee to maintain a top priority for the UNIVERSITY?                   |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 8.     | Please complete  the following questions:                                                             |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
|   | Total number of  employees in your company                                                            |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
|   | Total years in  business with this company name                                                       |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 9.     | Did your company  provide financial information under separate cover to the Director of Purchasing?   |   |    |            |            |
|   |                                                                                                  |   |    |            |            |
| 10.    | Are there any  conflicts of interest in doing business with the University?                           |   |    |   Yes |            |   |
|   |                                                                                                  |   |    |   No  |            |   |

 

32

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**SCHEDULE E**

** **

**REPRESENTAT****IONS, CERTIFICATIONSAND OTHER STATEMENTS OFOFFERORS OR QUOTERS (VENDORS)**

 

33

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**PART IV- SECTION KRepresentations,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 bythe Offeror:**(TheRepresentations and Certifications must be executed by an individual authorizedto bind the offeror.)**The offeror makes the followingRepresentations and Certifications as part of its proposal**(check/complete all appropriate boxes or blanks onthe.  following pages).**

 
|                                       |       |           |
|--------------------------------------------|------------|----------------|
| **(Name of Offeror)**                      |       | **(RFP  No.)** |
|                                       |       |
|                                       |       |           |
| **(Signature  of Authorized Individual)**  | **(Date)** |
|                                       |       |
| **(Typed  Name of Authorized Individual)** |       |

 

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

 

34

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**29.**                               **52.203-2 CERTIFICATE OF INDEPENDENT PRICEDETERMINATION   (APRIL 1985)**

 

**[NOTE: This provision is applicablewhen a firm-fixed price or fixed-price with economic price adjustment contractis contemplated.]**

 

(a)                                  Theofferor certifies that -

 

(1)                                  Theprices in this offer have been arrived at independently, without, for thepurpose of restricting competition, any consultation, communication, oragreement 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 tocalculate the prices offered;

 

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

 

(3)                                  Noattempt has been made or will be made by the offeror to induce any otherconcern to submit or not to submit an offer for the purpose of restrictingcompetition.

 

(b)                                 Eachsignature on the offer is considered to be a certification by the signatorythat the signatory-

 

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

 

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

 

**[insertfull name of person(s) in the offeror’s organization responsible fordetermining the prices offered in this bid or proposal, and the title of his orher position in the offeror’s organization];**

 

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

 

(iii)                               Asan agent, has not personally participated, and will not participate, in anyaction contrary to subparagraphs (a)(1) through (a)(3) above.

 

(c)                                  Ifthe offeror deletes or modifies subparagraph (a)(2) above, the offeror mustfurnish with its offer a signed statement setting forth in detail thecircumstances of the disclosure.

 

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

 

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

 

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

 

(1)                                  NoFederal appropriated funds have been paid or will be paid, to any person forinfluencing or attempting to influence an officer or employee of any agency, aMember of Congress, an officer or employee of Congress, or

 

35

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an employee of a Memberof Congress on his or her behalf in connection with the awarding of a contractresulting from this solicitation.

 

(2)                                  Ifany funds other than Federal appropriated funds (including profit or feereceived under a covered Federal transaction) have been paid, or will be paid,to any person for influencing or attempting to influence an officer or employeeof any agency, a Member of Congress, an officer or employee of Congress, or anemployee 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)                                  Heor she will include the language of this certification in all subcontractawards at any tier and require that all recipients of subcontract awards inexcess of $100,000 shall certify and disclose accordingly.

 

(c)                                  Submissionof this certification and disclosure is a prerequisite for making or enteringinto this contract imposed by section 1352, Title 31, United States Code.  Any person who makes an expenditureprohibited under this provision or who fails to file or amend the disclosureform to be filed or amended by this provision, shall be subject to a civilpenalty of not less than $10,000, and not more than $100,000, for each suchfailure.

 

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

 

(1)                                  Definitions.

 

***Common parent***, as used in thisprovision, means that corporate entity that owns or controls an affiliatedgroup of corporations that files its Federal income tax returns on aconsolidated 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 RevenueService (IRS) to be used by the offeror in reporting income tax and otherreturns.  The TIN may be either a SocialSecurity Number or an Employer Identification Number.

 

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

 

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

 

(4)                                  TaxpayerIdentification Number (TIN).

 

o                                    TIN:o                                    TINhas been applied for.o                                    TINis not required because:

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

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

 

36

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(5)                                  Typeof organization.

oSole proprietorship;

ýPartnership;

oCorporate entity (not tax-exempt);

oCorporate entity (tax-exempt);

oGovernment entity (Federal, State, or local); oForeign government;

oInternational organization per 26 CFR 1.6049-4;

oOther

 

(6)                                  Commonparent.

 

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

oName and TIN of common parent:

Name

TIN

 

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

 

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

 

(b)                                 *Representation. (Complete only if the offeror is a women-owned business concern and hasnot represented itself as a small business concern in paragraph (b)(1) of FAR52.219-1, Small Business Program Representations, of this solicitation.]*

 

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

 

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

 

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

 

(b)                                 Ifthe offeror does not have a DUNS number, it should contact Dun and Bradstreetdirectly to obtain one.  A DUNS numberwill 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 Bradstreetat 1-800-333-0505.  The offeror shouldbe prepared to provide the following information:

 

(1) Company name.(2) Company address.(3) Company telephone number.  (4) Lineof 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)                                  Offerorslocated outside the United States may obtain the location and phone number ofthe local Dun and Bradstreet Information Services office from the Internet homepage at http://www.customerservice@dnb.com. If an offeror is unable to locate a local service center, it may send ana-mail to Dun and Bradstreet at globalinfo@mail.dnb.com.

 

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**34.          52-.209-5 CERTIFICATION REGARDINGDEBARMENT, SUSPENSION, PROPOSED SUSPENSION, PROPOSED DEBARMENT AND OTHERRESPONSIBILITY MATTERS (DECEMBER 2001)**

 

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

 

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

 

(i)                                     TheOfferor and/or any of its Principals -

 

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

 

*(B)*                                Have o, have not o, within a three-yearperiod preceding this offer, been convicted of or had a civil judgment renderedagainst them for: commission of fraud or a criminal offense in connection withobtaining, attempting to obtain, or performing a public (Federal, state orlocal) contract or subcontract; violation of Federal or state antitrust statutesrelating to the submission of offers; or commission of embezzlement, theft,forgery, bribery, falsification or destruction of records, making falsestatements, 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) ofthis provision.

 

(ii)                                  TheOfferor has o, has not o,within a three-year period preceding this offer, had one or more contractsterminated 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 supervisoryresponsibilities within a business entity (e.g., general manager, plantmanager, head of a subsidiary, division, or business segment, and similarpositions).

 

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

 

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

 

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

 

(d)                                 Nothingcontained in the foregoing shall be construed to require establishment of asystem of records in order to render, in good faith, the certification requiredby paragraph (a) of this provision.  Theknowledge and information of an Offeror is not required to exceed that which isnormally possessed by a prudent person in the ordinary course of businessdealings.

 

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

 

38

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addition to other remedies available to theGovernment, the Contracting Officer may terminate the contract resulting fromthis solicitation for default.

 

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

 

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

 

(b)                                 Ifthe 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 solicitationsexceeding the micro-purchase threshold when the contract is to be performed inthe United States, its territories or possessions, Puerto Rico, the TrustTerritory of the Pacific Islands, or the District of Columbia.)

 

(a)                                  (1)                                  TheNorth American Industry Classification System (NAICS) code for this acquisitionis [INSERT NAICS CODE).

 

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

 

(3)                                  Thesmall business size standard for a concern which submits an offer in its ownname, other than on a construction or service contract, but which proposes tofurnish a product which it did not itself manufacture, is 500 employees.

 

(b)                                 **Representations.**

 

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

 

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

 

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

 

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

 

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

 

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

 

39

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(1)                                  Ito is, ois not a HUBZone small business concern listed, on the date of thisrepresentation, on the List of Qualified HUBZone Small Business Concernsmaintained by the Small business Administration, and no material change inownership and control, principal office, or HUBZone employee percentage hasoccurred since it was certified by the Small Business Administration inaccordance with 13 CFR part 126; and

 

(2)                                  Ito is, ois 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 accuratefor the HUBZone small business concern or concerns that are participating inthe joint venture.  *(The offeror shall enter the name or names of theHUBZone small business concern or concerns that are participating in the jointventure: ]*  Each HUBZonesmall business concern participating in the joint venture shall submit a separatesigned copy of the HUBZone representation.

 

(c)                                  **Definitions**.  As used in this provision-

 

**Service-disabledveteran-owned small business concern-**

 

(1)                                  Meansa small business concern-

 

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

 

(ii)                                  TheManagement and daily business operation of which are controlled by one or moreservicedisabled veterans or, in the case of a veteran with permanent and severedisability, the spouse or permanent caregiver of such veteran.

 

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

 

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

 

**Women-ownedsmall business concern,**means a small business concern-

 

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

 

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

 

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

 

(1)                                  Notless than 51 percent of which is owned by one or more veterans (as defined at38 U.S.  C.  101(2)) or, in the case of any publicly owned business, not lessthan 51 percent of the stock of which is owned by one or more veterans; and

 

(2)                                  Themanagement and daily business operations of which are controlled by one or moreveterans.

 

40

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(d)                                 Notice.

 

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

 

(2)                                  Under15 U.S.C.  645(d), any person whomisrepresents a firm’s status as a small, HUBZone small, small disadvantaged,or women-owned small business concern in order to obtain a contract to beawarded 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 lawthat specifically references section 8(d) for a definition of programeligibility, shall

 

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

 

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

 

(iii)                               Beineligible for participation in programs conducted under the authority of theAct.

 

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

 

(This representation must be completed if the acquisition is for one ofthe four designated industry groups of the Small Business CompetitivenessDemonstration Program specified in FAR 19.1005(a) (includes ConstructionContracts under NAICS codes that comprise Industry Subsectors 233, 234 and235].)

 

(a)                                  **Definition**

 

“Emerging small business” as used in thissolicitation, means a small business concern whose size is no greater than 50percent of the numerical size standard applicable to the North AmericanIndustry Classification System (NAICS) code assigned to a contractingopportunity.

 

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

 

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

 

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

 

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

 
| **Number of Employees**                                                                                       |   | **Average  Annual Gross Revenues** |
|---------------------------------------------------------------------------------------------------------------|--------|------------------------------------|
|                                                                                                          |   |                               |
| o                 50 or fewer |   | o  $1 million or less              |
| o                 51-100      |   | o  $1,000,001 - $2 million         |
| o                 101-250     |   | o  $2,000,001 - $3.5 million       |
| o                 251- 500    |   | o  $3,500,001 - $5 million         |
| o                 501 - 750   |   | o  $5,000,001 - $10 million        |
| o                 751-1,000   |   | o  $10,000,001 - $17 million       |
| o                 Over 1,000  |   | o  Over $17 million                |

 

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**38.  52.219-21 SMALL BUSINESS SIZEREPRESENTATION FOR TARGETED INDUSTRY CATEGORIES UNDER THE SMALL BUSINESSCOMPETITIVENESS DEMONSTRATION PROGRAM (MAY 1999)**

** **

**(Completeonly if the Offeror has represented itself under the provision 52.219-1 as asmall business concern under the size standards of this solicitation.)**

** **

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

 

Offeror’s numberof employees for the past twelve months**(check this column if size standard stated in solicitation is expressed interms of number of employees) or**Offeror’s average annualgross revenue for the last three fiscal years**(check this column if size standard stated in solicitation is expressed interms of annual receipts).  (Check oneof 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 BUSINESSSTATUS**

 

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

 

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(a)                                  **General**. This provision is used to assess an offeror’s small disadvantagedbusiness status for the purpose of obtaining a benefit on thissolicitation.  Status as a smallbusiness and status as a small disadvantaged business for general statisticalpurposes is covered by the provision at FAR 52.219-1, Small Business ProgramRepresentation.

 

(b)                                 **Representations**

 

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

 

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

* *

*(A)*                              No material change indisadvantaged ownership and control has occurred since its certification;

* *

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

* *

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

 

o            (ii)          It has submitted acompleted application to the Small Business Administration or a PrivateCertifier to be certified as a small disadvantaged business concern inaccordance with 13 CFR 124, Subpart B, and a decision on that application ispending, and that no material change in disadvantaged ownership and control hasoccurred since its application was submitted.

 

(2)                                  o                                    **For Joint Ventures**.  The offeror represents, as part of itsoffer, that it is a joint venture that complies with the requirements at 13 CFR124.1002(f) and that the representation in paragraph (b)(1) of this provisionis accurate for the small disadvantaged business concern that is participatingin the joint venture*.  [The offeror shall enter the name of thesmall disadvantaged business concern that is participating in the jointventure:                     ]*

 

(c)                                  **Penalties and Remedies**.  Anyone who misrepresents any aspects of thedisadvantaged status of a concern for the purposes of securing a contract orsubcontract shall:

 

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

 

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

 

(3)                                  Beineligible for participation in programs conducted under the authority of theSmall Business Act.

** **

**AlternateI (OCTOBER 1998)**

** **

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

 

As prescribed in19.306(b), add the following paragraph (b)(3) to the basic provision:

 

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

 

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list of authorizedsmall disadvantaged business procurement mechanisms and regions is posted athttp://www.arnet.gov/References/sdbadiustments.htm  The offeror shall use the list in effect on the date of thissolicitation.  “Address,” as used inthis provision, means the address of the offeror as listed on the SmallBusiness Administration’s register of small disadvantaged business concerns orthe address on the completed application that the concern has submitted to theSmall Business Administration or a Private Certifier in accordance with 13 CFRpart 124, subpart B.  For jointventures, “address” refers to the address of the small disadvantaged businessconcern that is participating in the joint venture.

** **

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

* *

*(Appliesto 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)                                  Exactedfrom any person under the age of 18 under the menace of any penalty for itsnonperformance and for which the worker does not offer himself voluntarily; or

 

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

 

2.                                       *Listed end products*.  The following end product(s) being acquiredunder this solicitation is (are) included in the List of Products RequiringContractor Certification as to Forced or Indentured Child Labor, identified bytheir country of origin.  There is areasonable basis to believe that listed end products from the listed countriesof origin may have been mined, produced, or manufactured by forced or indenturedchild labor.

 

Listed End Product

 

Listed Countries ofOrigin

 

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

 

o            (1)          Theofferor will not supply any end product listed in paragraph (b) of thisprovision that was mined, produced, or manufactured in a corresponding countryas listed for that end product.

 

o            (2)          Theofferor may supply an end product listed in paragraph (b) of this provision thatwas mined, produced, or manufactured in the corresponding country as listed forthat product.  The offeror certifiesthat it has made a good faith effort to determine whether forced or indenturedchild labor was used to mine, produce, or manufacture such end product.  On the basis of those efforts, the offerorcertifies 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 thisclause, means any waiting rooms, work areas, rest rooms and wash rooms,restaurants and other eating areas, time clocks, locker rooms and other storageor dressing areas, parking lots, drinking fountains, recreation orentertainment areas, transportation, and housing facilities provided foremployees, that are segregated by explicit directive or are in fact segregatedon the basis of race, color, religion, sex, or national origin because ofwritten or oral policies or employee custom. The term does not include separate or single-user rest rooms ornecessary dressing or sleeping areas provided to assure privacy between thesexes.

 

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

 

(c)                                  TheContractor shall include this clause in every subcontract and purchase orderthat is subject to the Equal Opportunity clause of this contract.

** **

**14.  52.222-22 PREVIOUS CONTRACTS ANDCOMPLIANCE REPORTS (FEBRUARY 1999)**

 

The offerorrepresents that -

 

(a)                                  Ito has, ohas not participated in a previous contract or subcontract subject to the EqualOpportunity clause of this solicitation;

 

(b)                                 Ito has, ohas not, filed all required compliance reports; and

 

(c)                                  Representationsindicating submission of required compliance reports, signed by proposedsubcontractors, will be obtained before subcontract awards.

** **

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

 

The offerorrepresents that (a) it ohas developed and has on file, o has notdeveloped and does not have on file, at each establishment, affirmative actionprograms required by the rules and regulations of the Secretary of Labor (41CFR 60-1 and 60-2), or (b) it o has notpreviously had contracts subject to the written affirmative action programsrequirement of the rules and regulations of the Secretary of Labor.

** **

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

 

By submission ofits offer, the offeror represents that, if it is subject to the reportingrequirements of 38 U.S.C.  4212(d)(i.e., if it has any contract containing Federal Acquisition Regulation clause52.222-37, Employment Reports on Special Disabled Veterans, Veterans of theVietnam Era, and Other Eligible Veterans), it has submitted the most recentVETS100 Report required by that clause.

** **

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

 

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

 

(a)                                  Thefollowing certification shall be checked:

 

**CERTIFICATION**

 

The offerorcertifies o, does notcertify o that: (1) The items of equipment to beserviced under this contract are commercial items which are used regularly forother than Government purposes, and are sold or traded by the Contractor insubstantial quantities to the general public in the course of normal businessoperations; (2) The contract services are furnished at prices which are, or arebased on, established catalog or market prices for the maintenance,calibration, and/or repair of certain information technology, scientific andmedical, and/or office and business

 

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equipment.  An “established catalog price” is a price(including discount price) recorded in a catalog, price list schedule, or otherverifiable and established record that is regularly maintained by themanufacturer or the Contractor and is either published or otherwise availablefor inspection by customers.  An “establishedmarket price” is a current price, established in the usual course of ordinaryand usual trade between buyers and sellers free to bargain, which can besubstantiated by data from sources independent of the manufacturer orContractor; and (3) The Contractor utilizes the same compensation (wage andfringe benefits) plan for all service employees performing work under thecontract as the Contractor uses for equivalent employees servicing the sameequipment of commercial customers.

 

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

 

(c)                                  Failureto execute the certification in paragraph (a) of this clause onto contact theContracting Officer as required in paragraph (b) of this clause may render thebid or offer nonresponsive.

** **

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

 

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

 

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

 

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

 

**NOTE:This certification is applicable for all solicitations for competitivecontracts expected to exceed $100,000 (including all options) and competitive8(a) contracts.  It is not applicable toacquisitions of commercial items, or to contracts where the contractor’sfacilities are located outside the United States (the “United States” includesany state of the United States, the District of Columbia, the Commonwealth ofPuerto Rico, Guam, American Samoa, the United States Virgin Islands, theNorthern Mariana Islands, and any other territory or possession over which theUnited States has jurisdiction)**

 

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

 

(b)                                 Bysigning this offer, the offeror certifies that-

 

(1)                                  Asthe owner or operator of facilities that will be used in the performance -ofthis contract that are subject to the filing and reporting requirementsdescribed in section 313 of the Emergency Planning and Community Right-to-KnowAct 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 continueto file for such facilities for the life of the contract the Toxic ChemicalRelease Inventory Form (Form R) as described in sections 313(a) and (g) of EPCRAand section 6607 of PPA; or

 

(2)                                  Noneof its owned or operated facilities to be used in the performance of thiscontract is subject to the Form R filing and reporting requirements becauseeach such facility is exempt for at least one of the following reasons: (Checkeach block that is applicable.)

 

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

 

o            (ii)                    Thefacility does not have 10 or more full-time employees as specified in section313(b)(1)(A) of EPCRA, 42 U.S.C. 11023(b)(1)(A);

 

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

 

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

 

o            (v)                   Thefacility is not located within any State of the United States, the District ofColumbia, the Commonwealth of Puerto Rico, Guam, American Samoa, the UnitedStates Virgin Islands, the Northern Mariana-Islands, or any other territory orpossession 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) foreigncontracts or 2) when one of the following two provisions (52.225-4, BuyAmerican Act–North American Free Trade Agreement—Israeli Trade Act Certificate,or 52.225-6, Trade Agreements Certificate) apply.**

 

(a)                                  Theofferor 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 thissolicitation entitled `Buy American Act—Supplies” and that the offeror hasconsidered components of unknown origin to have been mined, produced, or manufacturedoutside the United States.  The offerorshall list as foreign end products those end products manufactured in theUnited States that do not qualify as domestic end products.

 

(b)                                 ForeignEnd Products:

 

Line Item No.:Country of Origin:                                                (Listas necessary)

 

(c)                                  TheGovernment will evaluate offers in accordance with the policies and proceduresof 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 morebut less than $169,000 EXCEPT for 1) foreign acquisitions or 2) acquisitionsthat are exempt from NAFTA and the Israeli Trade Act.  (See FAR 25.401).]**

 

(a)                                  Theofferor 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 clauseof this solicitation entitled, `Buy American Act—North American Free TradeAgreement–Israeli Trade Act”) and that the offeror has considered components ofunknown origin to have been mined, produced, or manufactured outside the UnitedStates.

 

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

 

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**NAFTACountry or Israeli End Products:**

Line Item No.:Country of Origin:

(List as necessary)

 

(c)                                  Theofferor shall list those supplies that are foreign end products (other thanthose listed in paragraph (b) of this provision) as defined in the clause ofthis solicitation entitled, “Buy American Act—North American Free TradeAgreement—Israeli Trade Act.” The offeror shall list as other foreign endproducts those end products manufactured in the United States that do notqualify as domestic end products.

 

**OtherForeign End Products**Line Item No.:Country of Origin:

(List as necessary)

 

(d)                                 TheGovernment will evaluate offers in accordance with the policies and proceduresof Part 25 of the Federal Acquisition Regulation.

 

**ALTERNATEI (MAY 2002)**As prescribed in 25.1101(b)(2)(ii), substitutethe 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)                                 Theofferor certifies that the following supplies are Canadian end products asdefined in the clause of this solicitation entitled `Buy American Act—NorthAmerican Free Trade Agreement—Israeli Trade Act”:

 

Canadian End Products: Line Item No.: 

(List as necessary)

 

**ALTERNATEII (MAY 2002)** As prescribed in 25.1101(b)(2)(iii), substitutethe 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)                                 Theofferor certifies that the following supplies are Canadian end products orIsraeli end products as defined in the clause of this solicitation entitled`Buy American Act-North American Free Trade Agreement—Israeli Trade Act”:

 

**Canadianor Israeli End Products**Line Item No.:Country of Origin:                                                (Listas necessary)

 

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

 

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

 

(a)                                  Theofferor 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 solicitationentitled “Trade Agreements.”

 

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(b)                                 Theofferor 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)                                  TheGovernment will evaluate offers in accordance with the policies and proceduresof Part 25 of the Federal Acquisition Regulation.  For line items subject to the Trade Agreements Act, theGovernment will evaluate offers of U.S: made, designated country, CaribbeanBasin country, or NAFTA country end products without regard to the restrictionsof the Buy American Act.  The Governmentwill consider for award only offers of U.S.-made, designated country, CaribbeanBasin country, or NAFTA country end products unless the Contracting Officerdetermines that there are no offers for those products or that the offers forthose products are insufficient to fulfill the requirements of thissolicitation.

 

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

 

(a)                                  Definitions.  As used in this provision-

 

*HistoricallyBlack College or University* means an institution determinedby the Secretary of Education to meet the requirements of 34 CFR 608.2.  For the Department of Defense, the NationalAeronautics and Space Administration, and the Coast Guard, the term alsoincludes any nonprofit research institution that was an integral part of such acollege or university before November 14, 1986.

 

*MinorityInstitution* means an institution of higher education meetingthe requirements of Section 1046(3) of the Higher Education Act of 1965 (20U.S.C.  1067k, including aHispanic-serving institution of higher education, as defined in Section316(b)(1) of the Act (20 U.S.C.  I101a.)).

 

(b)                                 Representation.  The offeror represents that it-

 

ois o is not a Historically Black College orUniversity; o is ois not a Minority Institution.

 

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

 

(a)                                  **Cost or charges for royalties.**  When the response to this solicitationcontains costs or charges for royalties totaling more than $250, the followinginformation shall be included in the response relating to each separate item ofroyalty or license fee:

 

(1)                                  Nameand address of licensor.

(2)                                  Dateof license agreement.

(3)                                  Patentnumbers, patent application serial numbers or other basis on which the royaltyis payable.

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

(5)                                  Percentageor dollar rate of royalty per unit.

(6)                                  Unitprice of contract item.

(7)                                  Numberof units.

(8)                                  Totaldollar amount of royalties.

 

(b)                                 **Copies of current licenses.**  In addition, if specifically requested bythe Contracting officer before execution of the contract, the offeror shallfurnish a copy of the current license agreement and an identification ofapplicable claims of specific patents.

 

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

 

**ALTERNATEI (APRIL 1984), 52.227-6 ROYALTY INFORMATION, (APRIL 1984)**

 

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

 

When the responseto this solicitation covers charges for special construction or specialassembly that contain costs or charges for royalties totaling more than $250,the following information shall be included in the response relating to eachseparate 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 byRoman numerals I through III.**

 

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

 

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

 

**I.**                                         **Disclosure Statement – Cost Accounting Practices andCertification**

 

(a)                                  Anycontract in excess of $500,000 resulting from this solicitation will be subjectto 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)                                 Anyofferor submitting a proposal which, if accepted, will result in a contractsubject to the requirements of 48 CFR Chapter 99 must, as a condition ofcontracting, submit a Disclosure Statement as required by 9903.202.  When required, the Disclosure Statement mustbe submitted as a part of the offeror’s proposal under this solicitation unlessthe offeror has already submitted a Disclosure Statement disclosing the practicesused 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 theinformation requested in paragraph (c) of Part I of this provision.

** **

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

 

(c)                                  Checkthe appropriate box below:

 

o            (1)          Certificateof Concurrent Submission of Disclosure Statement.

 

The offeror herebycertifies that, as part of the offer, copies of the Disclosure Statement havebeen submitted as follows:

 

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

 

(ii)                                  onecopy to the cognizant Federal auditor.

 

**(Disclosuremust be on Form No.  CASB DS-1 or CASBDS-2, as applicable..  Forms may beobtained from the cognizant ACO or Federal official and/or from the looseleafversion of the Federal Acquisition Regulation).**

 

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

 

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

 

o            (2)          Certificateof Previously Submitted Disclosure Statement.

 

The offeror hereby certifies that the requiredDisclosure 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 usedin estimating costs in pricing this proposal are consistent with the costaccounting practices disclosed in the applicable Disclosure Statement.

 

o            (3)          Certificateof Monetary Exemption.

 

The offeror hereby certifies that the offeror togetherwith all divisions, subsidiaries, and affiliates under common control, did notreceive net awards of negotiated prime contracts and subcontracts subject to CAStotaling more than $50 million or more in the cost accounting periodimmediately preceding the period in which this proposal was submitted.  The offeror further certifies that if suchstatus changes before an award resulting from this proposal, the offeror willadvise the Contracting Officer immediately.

 

o            (4)          Certificateof Interim Exemption.

 

The offeror hereby certifies that:

 

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

 

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

 

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

 

o            (5)          Certificateof 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 requiredto submit a Disclosure Statement after receipt of this award, the offerorhereby certifies that ***(checkone and complete):***

 

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

 

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

 

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

 

51

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**II.  Cost Accounting Standards — Eligibilityfor Modified Contract Coverage**

 

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

 

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

 

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

 

**III.  Additional Cost Accounting StandardsApplicable to Existing Contracts**

 

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

 
|   | o  YES |   | o  NO |
|--------|--------|--------|-------|

 

**26.  CERTIFICATION REGARDING ENVIRONMENTAL TOBACCOSMOKE (DECEMBER 1994)**

 

**(Note:This certification applies only to those contract which contain provisions forchildren’s services.  The offeror’ssignature on the face page of these Representations and Certificationsconstitutes certification by the submitting organization of its compliance withthe Act.)**

 

Public Law 103-227, also known as the Pro-Children Actof 1994 (Act), requires that smoking not be permitted in any portion of anyindoor facility owned or leased or contracted for by an entity and usedroutinely or regularly for the provision of health, day care, early childhooddevelopment services, education or library services to children under the ageof 18, if the services are funded by Federal programs either directly orthrough State or local governments, by Federal grant, contract, loan, or loanguarantee.  The law also applies tochildren’s services that are provided in indoor facilities that areconstructed, operated, or maintained with such federal funds.  The law does not apply to children’sservices provided in private residences; portions of facilities used forinpatient drug or alcohol treatment; service providers whose sole source ofapplicable federal funds is Medicare or Medicaid; or facilities where WICcoupons are redeemed.  Failure to complywith the provisions of the law may result in the imposition of a civil monetarypenalty of up to $1,000 for each violation and/or the imposition of anadministrative compliance order on the responsible entity.

 

By signing this certification, the offeror/contractor(for acquisitions) or applicant/grantee (for grants) certifies that thesubmitting organization will comply with the requirements of the Act and willnot allow smoking within any portion of any indoor facility used for theprovision of services for children as defined by the Act.

 

The submitting organization agrees that it willrequire that the language of this certification be included in any subawardswhich contain provisions for children’s services and that all subrecipientsshall certify accordingly.

 

**27.  CERTIFICATION OF INSTITUTIONAL POLICY ONCONFLICT OF FINANCIAL INTEREST****(OCTOBER 1995)**

 

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

 

52

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By submission of its offer, the offeror certifiesthat:

 

(1)                                  Awritten and enforced administrative process to identify and manage, reduce oreliminate conflicting financial interest with respect to all research projectsfor which funding is sought from the NIH is o,is not o currently in effect.

 

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

 

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

 

**(Whencost or pricing data are required in accordance with FAR 15.406-2, theContracting Officer will request that the offeror complete, execute, and submitto the Contracting Officer a certification in the format shown in the followingCertificate of Current Cost or Pricing Data. The certification shall be submitted only at the time negotiations areconcluded.  Offerors should complete thecertificate and return it when requested by the Contracting Officer.)**

 

This is to certify that, to the best of my knowledgeand belief, the cost or pricing data (as defined in section 15.401 of theFederal Acquisition Regulation (FAR) and required under FAR subsection15.403-4) submitted, either actually or by specific identification in writing,to the Contracting Officer or to the Contracting Officer’s representative insupport of          * areaccurate, complete, and current asof          **.

 

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

 

Firm

 

Signature Name Title

 

Date of execution***

 

----

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

 

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

 

***                           Insert theday, month, and year of signing, which should be as close as practicable to thedate when the price negotiations were concluded and the contract price wasagreed to.

 

(End of Certificate)

 

53

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**[Attachment 2]**

 
| **WAYNE STATE UNIVERSITY** |   | Purchasing Department   |
|----------------------------|--------|-------------------------|
|                       |   | Detroit, Michigan 48202 |
|                       |   | (313) 577-3734          |
|                       |   | FAX (313) 577-3747      |
|                       |   |                    |
|                       |   | December 30, 2002       |

 

**AddendumOne (1) ToRequest for Proposalfor Genotyping ServicesDecember 16, 2002**

 

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

 

**Question 1**                                    Pertainingto 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 haplotypeand allele frequency information for polymorphisms in the candidate genes fromdifferent ethnic groups, and assist in identifying suitable polymorpisms forthe study.”*, our questions are as follows: * Is this informationexpected to be obtained from the public databases? * If this information is notavailable in the public databases, what is expected of the vendor? Should thevendor propose to develop this information for the public SNPs as part of thecontract? * We have developed proprietary sequence variation information,including frequency and haplotypes, for over 5,000 genes.  If the investigators wish to gain access tothis information for use in the proposed project, a separate agreement dealingwith intellectual proprietary and confidentiality will have to be negotiatedwith us.

 

***Answer 1***                                             *In response to your question, we would like tosuggest 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 aspossible to be able to evaluate both options from many different aspects(legal, intellectual, scientific, cost etc.).*

 

**Question 2**                                    Weunderstand that 200 genes have been chosen for this study.  What specific information is available onthe 200 genes?  Are they in the publicdomain?  How many polymorphisms arethere in the 200 genes?  Are thesequences known and provided?

 

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

 

*Yes,the genes are in the public domain.*

 

54

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*Thisis one of the tasks that we are asking the VENDOR to help us with.  The number of polymorphisms to be typed at aspecific locus will depend on the informativeness of the polymorphisms (seebelow).*

 

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

 

**Question3**                                    Forthe 4000 specimens, is pedigree and ethnicity information provided?

 

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

 

**Question4**                                    Isthe PEP-amplified DNA sufficient in quantity for downstream genotyping?  Can we assume the Vendor is not responsiblefor deficiencies in template integrity?

 

***Answer 4***                                             *Yes. Extensive testing has been done.*

** **

**Question5**                                    Weunderstand that the proposal is due Jan. 9. We find this an unreasonable deadline in view of the amount ofinformation that must be assembled for the proposal.  Can this date be extended?

*** ***

***Answer 5***                                             *We’re sorry, but we will be unable to extend thedeadline.*

** **

**Question6**                                    Whatis the time frame for the project (a one-year or three-year project)?  In other words, when do you expect to finishthe 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.*

** **

**Question7**                                    Isthis RFP a small business set aside (limited to small business only)?

*** ***

***Answer 7***                                             *Our RFP was originally sent to small businesses, butwe are not limiting the applicants or the selected VENDOR to being a smallbusiness.*

** **

**Question8**                                    Doyou have preference to the type of SNP genotyping for this RFP?

*** ***

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

** **

**Question9**                                    WSUwill 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 (PrimerExtension Preamplified) DNA.*

** **

**PLEASENOTE:**  In the RFP, wemade references to an Excel spreadsheet and disk.  However, after first drafting the RFP, we decided not to use acomplicated spreadsheet, but rather to allow

 

55

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each Vendor thelatitude to provide pricing using the simple table in Schedule C as aguideline.  However, we neglected todelete references to the spreadsheet and disk. **Please disregard them!**

 

As a reminder, inorder for Proposals to be considered, they must be received by the Universityon the due date and place as follows:

 

**Thursday,January 9, 2003 - 4:00 p.m.**Wayne State UniversityAttn: Kimberly Tomaszewski, Senior BuyerRFP - Genotyping Services5700 Cass Avenue, Suite 4200 AABDetroit, MI 48202

 

If you havequestions 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 DohertyAssociate Director of Purchasing

 

56

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**[Attachment3]**

** **
| **WAYNE STATE UNIVERSITY** |   | Purchasing Department   |
|----------------------------|--------|-------------------------|
|                       |   | Detroit, Michigan 48202 |
|                       |   | (313) 577-3734          |
|                       |   | FAX (313) 577-3747      |
|                       |   |                    |
|                       |   | January 07, 2003        |

 

**Addendum Number Two (2) ToRequest for Proposalfor Genotyping ServicesDecember 16, 2002**

 

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

** **

**Question10**                             Pleaseclarify the number of SNPs to be determined and the time-line.  Based on Answer 2 and Answer 6 in thecommunication dated December 30, 2002, and information in the RFP, the Vendorwould need to perform approximately 4.16 million SNPs in 6 months (200 genes X4 SNPs per gene X 4000 DNAs X 30% repeat analyses).  Is this correct?

*** ***

***Answer 10***                                      *Yes, that is correct.*

** **

**Question11**                             Couldyou please estimate of approximately how many hours of labor effort (bothprofessional and technical) would be required for this contract?  This labor effort estimation is commonlyprovided in government RFPs.

*** ***

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

** **

**Question12**                             Itwould be difficult for us to estimate how many professional labor hours wouldbe required for the Vendor to “evalutate the usefulness of the knownpolymorphisms for our (WSU) study”.  Todo this properly, the Vendor must become familiar with the current and relatedliterature in studies which are similar to the WSU study.  Would more details on the project beprovided to the Vendor than the brief background provided on page 13 of theRFP?

*** ***

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

** **

**Question13**                             Doyou anticipate making one single award or multiple awards as a result of thisRFP?

 

57

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***Answer 13***                                      *????????????*

** **

**Question14**                             Ifa Vendor does not have a propriatory database with haplotype data, would use ofpublic databases suffice, or would the Vendor be at a disadvantage compared toanother Vendor with this resource?

*** ***

***Answer 10***                                      *Depends on cost associated with getting suchinformation.  Difficult to answer atthis time.*

 

As a reminder, inorder for Proposals to be considered, they must be received by the Universityon the due date and place as follows:

** **

**Thursday,January 9, 2003 - 4:00 p.m.**Wayne State UniversityAttn:  Kimberly Tomaszewski, SeniorBuyerRFP - Genotyping Services5700 Cass Avenue, Suite 4200 AABDetroit, MI 48202

 

If you havequestions 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 DohertyAssociate Director of Purchasing

 

58

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**[Attachment 4]**

 

7 January 2003

 

Joan M. Grossman,C.P.M.Wayne State UniversityPurchasing Department4th floor, Suite 4200 AAB5700 Cass AvenueDetroit, MI 48202

 

**Re:**                               RFP Genotyping ServicesDUNS number: 78-949-7310

 

Dear Ms. Grossman:

 

We are respondingto the above referenced RFP.  As per theinstructions in the Request for Proposal and Specifications for GenotypingServices, we are submitting the following information:

 

•                  Genaissance’sprofile as described in **Exhibit 2**,which is part of the proposal being submitted in response to the abovereferenced RFP.

 

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

 

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

 

Should you haveany questions about our financial information, please do not hesitate tocontact us.

 
|   | Sincerely,                |
|--------|---------------------------|
|   |
|   | /s/ Gerald F. Vovis       |   |
|   | Executive Vice  President |
|   | Chief Technology  Officer |

 

Enclosures

 

----

 

7 January 2003

 

Kimberly TomaszewskiSenior BuyerWayne State UniversityPurchasing Department4th floor, Suite 4200 AAB5700 Cass AvenueDetroit, MI 48202

 

Re:                               RFPGenotyping ServicesDUNS number: 78-949-7310

 

Dear Ms. Tomaszewski:

 

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

 

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

 

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

 

Genaissance considers our prices for doing genotyping services to beconfidential and, hence, the prices for the Company’s services that are listedon Schedule C are proprietary information.

 

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

 

Should you have any questions about our proposal, please do nothesitate to contact us.

 
|   | Sincerely,                |
|--------|---------------------------|
|   |
|   | /s/ Gerald F. Vovis       |   |
|   | Executive Vice  President |
|   | Chief Technology  Officer |

 

Enclosures

 

59

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**Tableof Contents**

 
| **Tab**         |   | **Section**                                                                           |
|-----------------|--------|---------------------------------------------------------------------------------------|
|            |   |                                                                                  |
| **Schedule A1** |   | Proposal  Certification                                                               |
|            |   |                                                                                  |
| **Schedule A2** |   | Non-Collusion  Affidavit                                                              |
|            |   |                                                                                  |
| **Schedule B**  |   | Insurance  Requirements                                                               |
|            |   |                                                                                  |
| **Schedule C**  |   | Price Schedule, Summary of  Quoted Rates                                              |
|            |   |                                                                                  |
| **Schedule D**  |   | Summary Questionnaire                                                                 |
|            |   |                                                                                  |
| **Schedule E**  |   | Representations,  Certifications and Other Statement of Offerors or Quoters (Vendors) |
|            |   |                                                                                  |
| **Exhibit 1**   |   | Exceptions/Restrictions                                                               |
|            |   |                                                                                  |
| **Exhibit 2**   |   | Profile/Experience/References                                                         |
|            |   |                                                                                  |
| **Exhibit 3**   |   | Vendor Service Plan                                                                   |
|            |   |                                                                                  |
| **Exhibit 4**   |   | Vendor Qualifications                                                                 |
|            |   |                                                                                  |
| **Exhibit 5**   |   | Small Business  Subcontracting Plan                                                   |
|            |   |                                                                                  |
| **Addendum  1** |   | Terms  and Conditions                                                                 |
|            |   |                                                                                  |
| **Addendum  2** |   | License  Agreement                                                                    |

 

60

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Schedule A.2

 

**NON-COLLUSION****AFFIDAVIT**

 

The undersigned, duly authorized to represent the persons; firms andcorporations joining and participating in the submission of the foregoingProposal (such persons, firms and corporations hereinafter being referred to asthe “VENDOR”), being duly sworn, on his or her oath, states that to the best ofhis or her belief and knowledge no person, firm or corporation, nor any personduly representing the same joining and participating in the submission of theforegoing Proposal, has directly or indirectly entered into any agreement orarrangement with any other VENDORS, or with any official of the UNIVERSITY orany employee thereof, or any person, firm or corporation under contract withthe UNIVERSITY whereby the VENDOR, in order to induce acceptance of theforegoing Proposal by said UNIVERSITY, has paid or is to pay to any otherVENDOR or to any of the aforementioned persons anything of value whatever, andthat the VENDOR has not, directly or indirectly entered into any arrangement oragreement with any other VENDOR or VENDORS which tends to or does lessen ordestroy free competition in the letting of the contract sought for by theforegoing 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 orperson, in connection with this solicitation, to submit a collusive or shambid, to refrain from bidding, to manipulate or ascertain the price(s) of otherproposers or potential proposers, or to obtain through any unlawful act anadvantage over other proposers or the college.

 

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

 

**CONFLICTOF INTEREST**

 

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

 

61

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

 
| 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 ofConnecticut.  My commissionexpires:  July 31, 2007

 

62

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Schedule A.1

 

**PROPOSAL CERTI****FICATION**

 

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

 

**RESPONSETO WAYNE STATE UNIVERSITYREQUEST FOR PROPOSAL FORPROVIDING GENOTYPING SERVICES FOR 2002 / 2003DATED: December 16, 2002**

 

**AND TOANY AMENDMENTS, THERETO**

 

The undersigned, duly authorized to represent the persons, firms andcorporations joining and participating in the submission of this Proposalstates that the Proposal contained herein is complete and is in strictcompliance with the requirements of the subject Request for Proposal datedDecember 16, 2002, except as noted in Exhibit 1, the “Restricted Services/Exceptionsto RFP” section of the Proposal.  Ifthere are no modifications, deviations or exceptions, state same as a part ofthe Proposal Certification Statement:

 

o    NONE        ý    Ifthere are, state YES

 

This proposal remains in effect for 120 days.

 

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

 
| Company Name: | Genaissance  Pharmaceuticals, Inc. |
|---------------|------------------------------------|
|          |                               |
| Address:      | 5 Science Park                     |
|          |                               |
|          | New Haven,  CT  06511         |
|          |                               |
| ATTN:         | Gerald F. Vovis,  Ph.D.            |
|          |                               |
| Tax Payer ID: | 06-1338846                         |
|          |                               |
| Submitted by: |                               |
|          |                               |
| Signature     | /s/ Gerald F.  Vovis, Ph.D.        |
|          |                               |
| Typed Name    | Gerald F. Vovis,  Ph.D.            |
|          |                               |
|          | Title:                             | Executive Vice  President  Chief Technology Officer |   | January 7, 2003 |
|          | (Title)                            | (Date) |

 

63

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**INSURANCE REQUI****REMENTS**

** **

Genaissance Pharmaceuticals, Inc., at its sole expense, shall cause tobe 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) |   |   |   |   |

 

**MaximumAcceptable 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

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Client #: 765                                                                                                                                                                                                                         GENAISSANCE
| ***ACORD***TM                                                                                     **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 LIABILITYý COMMERCIAL  GENERAL  LIABILITYoo 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 LIABILITYo  ANY AUTOo  ALL OWNED AUTOSo  SCHEDULED AUTOSý  HIRED AUTOSý  NON-OWNED AUTOSo                                     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 LIABILITYo ANY AUTOo |   |   |   |   |   |   |   | AUTO ONLY – EA ACCIDENT |   |   |   |
| OTHER THAN AUTO ONLY:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            | EA ACC  AGG                                                                                                                                                                                                          | $ |   |
| $                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                 |
|                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                 |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| A                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |                                                                                                                                                                                                                 |   |   | EXCESS/UMBRELLA LIABILITYý  OCCUR    o  CLAIMS MADEo  DEDUCTIBLEo  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

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**IMPORTANT**

 

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

 

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

 

**DISCLAIMER**

 

The Certificate of Insurance on the reverse side of this form does notconstitute a contract between the issuing insurer(s), authorized representativeor producer, and the certificate holder, nor does it affirmatively ornegatively amend, extend or alter the coverage afforded by the policies listedthereon.

 

66

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**SCHEDULE C - PriceSchedule**Reply to Wayne State University Request for ProposalFor Genotyping Services

 

The following price schedule is based on a project size of 4,000 DNAsamples genotyped with 800 SNP assays (200 genes with 4 SNPs each), with arandom selection of 30% of the assays run a second time and delivery of [**]%of the total possible data.  Genaissanceestimates a turnaround time of 20 weeks to complete this proposed project.  Changes in either the number of DNA samplesor 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 randomlyrepeated assays as requested.

 

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

 

The PRB investigators requested haplotype and allele frequencyinformation for public polymorphisms. In order to provide such information, all of the polymorphisms in acandidate gene should be genotyped on the same panel of individuals of diverseethnic background.  From suchinformation, haplotypes could then be built for various diversepopulations.  Genaissance hasconstructed a reference panel consisting of individuals whose four grandparentshad the same ethnic background.  Thepanel, which the Company uses to discover its proprietary polymorphisms andbuild haplotypes, consists of the following:

 

•             Eighty-twounrelated individuals:

 

•                       21Caucasians of Western European extraction;

 

•                       20African-Americans;

 

•                       20Asians;

 

Confidential andProprietary

 

1

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•                       18Hispanic/Latinos; and

 

•                       3Native Americans.

 

•             Elevenrelated individuals:

 

•                       6Caucasians (4 grandparents) and

 

•                       5African-Americans (2 parents).

 

•             Threecontrols:

 

•                       1chimpanzee;

 

•                       1gorilla; and

 

•                       1negative control.

 

The cost to generate a genotype for each individual in the referencepanel is $[**].  Genaissance would thenbuild the haplotypes from the resulting information using its proprietary *HAPTM* Builder technology and know-how.

 

**Alternateproposals for this solicitation are not acceptable.**  As requested in your **Addendum to Request for Proposal for GenotypingServices of December 16, 2002 (Question and Answer 1)**, we areproviding an alternate proposal, in which Genaissance proprietary SNPs andhaplotypes (referred to herein as *HAPTM*Markers) would be used in the proposed project.

 

**An Alternate Proposal for Genotyping**

 

**Useof Genaissance’s Proprietary *HAPTM*Markers**.  If WSUdecides to use Genaissance’s proprietary *HAPTM*Markers, the work would proceed as follows. The PRB investigators would identify the candidate genes to be genotypedand supply Genaissance with the list of candidate genes and the ethnicbackground of the patients to be genotyped. Genaissance would then use its proprietary *HAPTM* Database to select the minimum number of SNPs (bothproprietary to Genaissance and in the public domain) that are needed to capture80% to 90% of the haplotype diversity present in this patient population.  The exact percentage would be decided uponin discussions between the PRB investigators, WSU and Genaissance.  In recent large-scale projects, Genaissancehas used an average of [**] SNPs per candidate gene to capture 90% of thehaplotype diversity present in the Caucasian population.

 

Genaissance would then design and validate assays for the selectedSNPs.  If validated assays could not bedeveloped for any of the SNPs, Genaissance would consult with the PRBinvestigators regarding whether any replacement SNPs should be selected to meetthe goal of capturing the agreed upon percentage of haplotype diversity presentin the patient population.  Genaissancewould design and validate assays for any replacement SNPs.  Once assays have been designed and validatedfor all selected SNPs, Genaissance would genotype each of the

 

2

----

 

selected SNPs in the patient samples, deduce haplotypes from theresultant genotypes for each gene and each patient using Genaissance’sproprietary *HAPTM* Buildertechnology and know-how, and supply the resultant genotypes and haplotypes foreach patient to WSU.

 

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

 

Because of the expanded nature of the project in this alternateproposal, 30 weeks would be required for completion of this proposedproject.  The price schedule for thisalternate 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 anadditional [**]% for randomly repeated assays as requested.

 

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

 

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

 

3

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| 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 Questionnair****e**

 
|   |   |                                                                                                  |   | **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  Yesý No |   |            |

 

1

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**SCHEDULE E**

 

**REPRESENTATIONS, CERTIFICATIONSAND OTHER STATEMENTS OFOFFERORS OR QUOTERS (VENDORS)**

 

----

 

**PART IV - SECTION K**

**Representations, Certifications, andOther 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 bythe Offeror: (**TheRepresentations and Certifications must be executed by an individual authorizedto bind the offeror.**) The offeror makes the followingRepresentations and Certifications as part of its proposal (**check/complete all appropriate boxes or blanks on thefollowing 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 inoffers 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 witheconomic price adjustment contract is contemplated.]**

 

(a)                                  Theofferor certifies that -

 

3

----

 

(1)                                  Theprices in this offer have been arrived at independently, without, for thepurpose of restricting competition, any consultation, communication, oragreement 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 tocalculate the prices offered;

 

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

 

(3)                                  Noattempt has been made or will be made by the offeror to induce any otherconcern to submit or not to submit an offer for the purpose of restrictingcompetition.

 

(b)                                 Eachsignature on the offer is considered to be a certification by the signatorythat the signatory—

 

(1)                                  Isthe person in the offeror’s organization responsible for determining the pricesbeing offered in this bid or proposal, and that the signatory has notparticipated 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 incertifying that those principals have not participated, and will notparticipate in any action contrary to subparagraphs (a)(1) through (a)(3) above

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

**[insertfull name of person(s) in the offeror’s organization responsible fordetermining the prices offered in this bid or proposal, and the title of his orher position in the offeror’s organization];**

 

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

 

(iii)                               Asan agent, has not personally participated, and will not participate, in anyaction contrary to subparagraphs (a)(1) through (a)(3) above.

 

4

----

 

(c)                                  Ifthe offeror deletes or modifies subparagraph (a)(2) above, the offeror mustfurnish with its offer a signed statement setting forth in detail thecircumstances of the disclosure.

** **

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

 

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

 

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

 

(1)                                  NoFederal appropriated funds have been paid or will be paid, to any person forinfluencing or attempting to influence an officer or employee of any agency, aMember of Congress, an officer or employee of Congress, or an employee of aMember of Congress on his or her behalf in connection with the awarding of acontract resulting from this solicitation.

 

(2)                                  Ifany funds other than Federal appropriated funds (including profit or feereceived under a covered Federal transaction) have been paid, or will be paid,to any person for influencing or attempting to influence an officer or employeeof any agency, a Member of Congress, an officer or employee of Congress, or anemployee of a Member of Congress on his or her behalf in connection with thissolicitation, the offeror shall complete and submit with its offer, OMBStandard Form-LLL, “Disclosure of Lobbying Activities”, to the ContractingOfficer, and

 

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

 

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

** **

 

5

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**31.**                               **52.204-3  TAXPAYERIDENTIFICATION (OCTOBER 1998)**

 

(1)                                  Definitions.

 

***Common parent***, as used in thisprovision, means that corporate entity that owns or controls an affiliatedgroup of corporations that files its Federal income tax returns on aconsolidated 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 RevenueService (IRS) to be used by the offeror in reporting income tax and otherreturns.  The TIN may be either a SocialSecurity Number or an Employer Identification Number.

 

(2)                                  Allofferors must submit the information required in paragraphs (d) through (f) ofthis 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 bythe IRS.  If the resulting contract issubject to the payment reporting requirements described in Federal AcquisitionRegulation (FAR) 4.904, the failure or refusal by the offeror to furnish theinformation may result in a 31 percent reduction of payments otherwise dueunder the contract.

 

(3)                                  TheTIN may be used by the Government to collect and report on any delinquentamounts arising out of the offeror’s relationship with the Government (31U.S.C. 7701(c)(3)).  If the resultingcontract is subject to the payment reporting requirements described in FAR4.904, the TIN provided hereunder may be matched with IRS records to verify theaccuracy of the offeror’s TIN.

 

(4)                                  TaxpayerIdentification 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)                                  Typeof 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

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| o | Foreign government;                             |
|---|-------------------------------------------------|
| o | International organization per 26 CFR 1.6049-4; |
| o | Other                                           |

 

(6)                                  Commonparent.

 
| 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-OWNEDBUSINESS (Other Than Small Business) (MAY 1999)**

 

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

 

(b)                                 *Representation. [Complete only if the offeror is a women-owned business concern and hasnot represented itself as a small business concern in paragraph (b)(1) of FAR52.219-1, Small Business Program Representations, of this solicitation.]*

 

The offeror representsthat it o is awomen-owned business concern.

** **

**33.**                               **52.204-6  DATAUNIVERSAL NUMBERING SYSTEM (DUNS) NUMBER (JUNE 1999)**

 

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

 

(b)                                 Ifthe offeror does not have a DUNS number, it should contact Dun and Bradstreetdirectly to obtain one.  A DUNS numberwill 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 Bradstreetat 1-800-333-0505.  The offeror shouldbe prepared to provide the following information:

 

(1)                                  Companyname.

 

(2)                                  Companyaddress.

 

(3)                                  Companytelephone number.

 

7

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(4)           Line of business.

 

(5)           Chief executive officer/key manager.

 

(6)           Date the company was started.

 

(7)           Number of people employed by thecompany.

 

(8)                                  Companyaffiliation.

 

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

** **

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

** **

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

 

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

 

(i)                                     TheOfferor and/or any of its Principals –

 

(A)                              Areo, are not ýpresently debarred, suspended, proposed for debarment, or declared ineligiblefor the award of contracts by any Federal agency;

 

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

 

(C)                                Areo, are not ýpresently indicted for, or otherwise criminally or civilly charged by agovernmental entity with, commission of any of the offenses enumerated insubdivision (a)(1)(i)(B) of this provision.

 

8

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(D)                               Ifthe offeror has responded affirmatively, the offeror shall provide additionalinformation if requested by the Contracting Officer; and

 

(ii)                                  TheOfferor has o, has not ý,within a three-year period preceding this offer, had one or more contractsterminated 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 supervisoryresponsibilities within a business entity (e.g., general manager, plantmanager, head of a subsidiary, division, or business segment, and similarpositions).

** **

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

 

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

 

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

 

(d)                                 Nothingcontained in the foregoing shall be construed to require establishment of asystem of records in order to render, in good faith, the certification requiredby paragraph (a) of this provision.  Theknowledge and information of an Offeror is not required to exceed that which isnormally possessed by a prudent person in the ordinary course of businessdealings.

 

(e)                                  Thecertification in paragraph (a) of this provision is a material representationof fact upon which reliance was placed when making an award.  If it is later determined that the Offerorknowingly rendered an erroneous certification, in addition to other remediesavailable to the Government, the Contracting Officer may terminate the contractresulting from this solicitation for default.

 

9

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**35.**                               **52.215-6  PLACEOF PERFORMANCE (OCTOBER 1997)**

 

(a)                                  Theofferor or respondent, in the performance of any contract resulting from thissolicitation, o intends, ýdoes not intend (check applicable block) to use one or more plants orfacilities located at a different addresses from the address of the offeror orrespondent as indicated in this proposal or response to request forinformation.

 

(b)                                 Ifthe 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  SMALLBUSINESS PROGRAM REPRESENTATIONS (APRIL 2002)**

 

(Note: Thisprovision applies to solicitations exceeding the micro-purchase threshold whenthe contract is to be performed in the United States, its territories orpossessions.  Puerto Rico, the TrustTerritory of the Pacific Islands, or the District of Columbia.)

 

(a)                                  (1)                                  TheNorth American Industry Classification System (NAICS) code for this acquisitionis [INSERT NAICS CODE].

 

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

 

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

 

(b)                                 **Representations**.

 

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

 

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

 

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

 

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

 

10

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as part of itsoffer that it o is, ýis not a veteran-owned small business concern.

 

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

 

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

 

(1)                                  Ito is, ýis not a HUBZone small business concern listed, on the date of thisrepresentation, on the List of Qualified HUBZone Small Business Concernsmaintained by the Small business Administration, and no material change inownership and control, principal office, or HUBZone employee percentage hasoccurred since it was certified by the Small Business Administration inaccordance with 13 CFR part 126; and

 

(2)                                  Ito is, ýis 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 forthe HUBZone small business concern or concerns that are participating in thejoint venture.  *[The offeror shall enter the name or names of theHUBZone small business concern or concerns that are participating in the jointventure.]*  Each HUBZone smallbusiness concern participating in the joint venture shall submit a separatesigned copy of the HUBZone representation.

 

(c)                                  **Definitions.**  As used in this provision—

** **

**Service-disabledveteran-owned small business concern—**

 

(1)                                  Meansa small business concern—

 

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

 

(ii)                                  TheManagement and daily business operation of which are controlled by one or moreservice disabled veterans or, in the case of a veteran with permanent andsevere-disability, the spouse or permanent caregiver of such veteran.

 

11

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

 

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

 

**Women-ownedsmall business concern**, means a small business concern—

 

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

 

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

** **

**Veteran-ownedsmall business concern**means a small business concern—

 

(1)                                  Notless than 51 percent of which is owned by one or more veterans (as defined at38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than51 percent of the stock of which is owned by one or more veterans; and

 

(2)                                  Themanagement and daily business operations of which are controlled by one or moreveterans.

 

(d)                                 **Notice**.

 

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

 

(2)                                  Under15 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 inorder to obtain a contract to be awarded under the preference programsestablished pursuant to section 8(a), 8(d), 9, or 15 of the Small Business Actor any other provision of Federal law that specifically references section 8(d)for a definition of program eligibility, shall—

 

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

 

12

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

 

(iii)                               Beineligible for participation in programs conducted under the authority of theAct.

 

**37.**                               **52.219-19  SMALLBUSINESS CONCERN REPRESENTATION FOR THE SMALL BUSINESS COMPETITIVENESSDEMONSTRATION PROGRAM (OCTOBER 2000)**

 

(Thisrepresentation must be completed if the acquisition is for one of the fourdesignated industry groups of the Small Business Competitiveness DemonstrationProgram specified in FAR 19.1005(a) (includes Construction Contractsunder 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 nogreater than 50 percent of the numerical size standard applicable to the NorthAmerican Industry Classification System (NAICS) code assigned to a contractingopportunity.

 

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

 

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

 

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

 

Offeror’s number ofemployees for the past twelve months **(checkthis column if size standard stated in solicitation is expressed in terms ofnumber of employees) or Offeror’s average annual gross revenue for the last 3fiscal years (Check this column if size standard stated in solicitation isexpressed 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

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

** **

**(Completeonly if the Offeror has represented itself under the provision 52.219-1 as asmall business concern under the size standards of this solicitation.)**

 

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

 

Offeror’s numberof employees for the past twelve months **(checkthis column if size standard stated in solicitation is expressed in terms ofnumber of employees)**or Offeror’s average annual gross revenuefor the last three fiscal years **(check thiscolumn if size standard stated in solicitation is expressed in terms of annualreceipts)**.  **(Check one of the following.)**

 
| **Number of Employees** |   | **Average  Annual Gross Revenues** |
|-------------------------|--------|------------------------------------|
|                    |   |                               |
| o  50 or fewer          |   | o  $1 million or less              |
|                    |   |                               |
| o  51 – 100        |   | o  $1,000,001 – $2 million    |
|                    |   |                               |
| o  101 – 250       |   | o  $2,000,001 – $3.5 million  |
|                    |   |                               |
| o  251 – 500       |   | o  $3,500,001 – $5 million    |
|                    |   |                               |
| o  501 – 750       |   | o  $5,000,001 – $10 million   |
|                    |   |                               |
| o  751 – 1,000     |   | o  $10,000,001 – $17 million  |
|                    |   |                               |
| o  Over 1,000           |   | o  Over $17 million                |

 

14

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The ten targetedindustries 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  SMALLDISADVANTAGED BUSINESS STATUS (OCTOBER 1999)**

** **

**(Note: This applies to competitivesolicitations over $100,000 under the SIC Major Groups for which a priceevaluation adjustment is applicable.)**

 

(a)                                  **General.** This provision is used to assess an offeror’s small disadvantagedbusiness status for the purpose of obtaining a benefit on thissolicitation.  Status as a smallbusiness and status as a small disadvantaged business for general statisticalpurposes is covered by the provision at FAR 52.219-1, Small Business ProgramRepresentation.

 

(b)                                 **Representations.**

 

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

 

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

 

(A)                              Nomaterial change in disadvantaged ownership and control has occurred since itscertification;

 

15

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(B)                                Wherethe concern is owned by one or more disadvantaged individuals, the net worth ofeach individual upon whom the certification is based does not exceed $750,000after taking into account the applicable exclusions set forth at 13 CFR124.104(c)(2); and

 

(C)                                Itis identified, on the date of its representation, as a certified smalldisadvantaged business concern in the database maintained by the Small BusinessAdministration (PRONet); or

 

o(ii)                      Ithas submitted a completed application to the Small Business Administration or aPrivate Certifier to be certified as a small disadvantaged business concern inaccordance with 13 CFR 124, Subpart B, and a decision on that application ispending, and that no material change in disadvantaged ownership and control hasoccurred since its application was submitted.

 

(2)o                      **For Joint Ventures**.  The offeror represents, as part of itsoffer, that it is a joint venture that complies with the requirements at 13 CFR124.1002(f) and that the representation in paragraph (b)(1) of this provisionis accurate for the small disadvantaged business concern that is participatingin the joint venture.  *[The offeror shall enter the name of the smalldisadvantaged business concern that is participating in the jointventure:                         .]*

 

(c)                                  **Penalties and Remedies**.  Anyone who misrepresents any aspects of thedisadvantaged status of a concern for the purposes of securing a contract orsubcontract shall:

 

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

 

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

 

(3)                                  Beineligible for participation in programs conducted under the authority of theSmall Business Act.

** **

**Alternate I (OCTOBER 1998)**

** **

**(Note: Applies when price evaluationadjustment for small disadvantaged business concerns is authorized on aregional basis.  Designated regions byMajor SIC Category can be found athttp://www.arnet.gov/References/sdbadjustments.htm.  Currently, this includes SIC Major Industry Groups 15, 16, 17which are all construction related groups.)**

 

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

 

16

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(3)                                  Address.  The offeror represents that itsaddress                    is,                     is not in a region for which a small disadvantaged business procurementmechanism is authorized and its address has not changed since its certificationas a small disadvantaged business concern or submission of its application forcertification.  The list of authorizedsmall disadvantaged business procurement mechanisms and regions is posted athttp://www.arnet.gov/References/sdbadjustments.htm  The offeror shall use the list in effect on the date of thissolicitation.  “Address,” as used inthis provision, means the address of the offeror as listed on the SmallBusiness Administration’s register of small disadvantaged business concerns orthe address on the completed application that the concern has submitted to theSmall Business Administration or a Private Certifier in accordance with 13 CFRpart 124, subpart B.  For jointventures, “address” refers to the address of the small disadvantaged businessconcern that is participating in the joint venture.

** **

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

* *

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

 

1.                                       *Definition*.

 

*Forcedor indentured child labor means all work or service—*

 

(1)                                  Exactedfrom any person under the age of 18 under the menace of any penalty for itsnonperformance and for which the worker does not offer himself voluntarily; or

 

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

 

2.                                       *Listed end products.*  The following end product(s) being acquiredunder this solicitation is (are) included in the List of Products RequiringContractor Certification as to Forced or Indentured Child Labor, identified bytheir country of origin.  There is areasonable basis to believe that listed end products from the listed countriesof origin may have been mined, produced, or manufactured by forced orindentured child labor.

 

Listed End Product

 

Listed Countries ofOrigin

 

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

 

17

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ý(1)                      The offeror will not supply anyend 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 endproduct listed in paragraph (b) of this provision that was mined, produced, ormanufactured in the corresponding country as listed for that product.  The offeror certifies that it has made agood faith effort to determine whether forced or indentured child labor wasused to mine, produce, or manufacture such end product.  On the basis of those efforts, the offerorcertifies that it is not aware of any such use of child labor.

** **

**13.**                               **52.222-21  CERTIFICATIONOF NONSEGREGATED FACILITIES (FEBRUARY 1999)**

 

(a)                                  *Segregated facilities*, as used in thisclause, means any waiting rooms, work areas, rest rooms and wash rooms,restaurants and other eating areas, time clocks, locker rooms and other storageor dressing areas, parking lots, drinking fountains, recreation orentertainment areas, transportation, and housing facilities provided foremployees, that are segregated by explicit directive or are in fact segregatedon the basis of race, color, religion, sex, or national origin because ofwritten or oral policies or employee custom. The term does not include separate or single-user rest rooms ornecessary dressing or sleeping areas provided to assure privacy between thesexes.

 

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

 

(c)                                  TheContractor shall include this clause in every subcontract and purchase orderthat is subject to the Equal Opportunity clause of this contract.

** **

**14.**                               **52.222-22  PREVIOUSCONTRACTS AND COMPLIANCE REPORTS (FEBRUARY 1999)**

 

The offerorrepresents that—

 

(a)                                  Itýhas, ohas not participated in a previous contract or subcontract subject to the EqualOpportunity clause of this solicitation;

 

(b)                                 Itý has, ohas not, filed all required compliance reports; and

 

18

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(c)                                  Representationsindicating submission of required compliance reports, signed by proposedsubcontractors, will be obtained before subcontract awards.

** **

**15.**                               **52.222-25  AFFIRMATIVEACTION COMPLIANCE (APRIL 1984)**

 

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

** **

**16.**                               **52.222-38  COMPLIANCEWITH VETERANS’ EMPLOYMENT REPORTING REQUIREMENTS (DECEMBER 2001)**

 

By submission of its offer, the offeror representsthat, 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 clause52.222-37, Employment Reports on Special Disabled Veterans, Veterans of theVietnam Era, and Other Eligible Veterans), it has submitted the most recentVETS-100 Report required by that clause.

** **

**17.**                               **52.222-48  EXEMPTIONFROM APPLICATION OF SERVICE CONTRACT ACT PROVISIONS FOR CONTRACTS FORMAINTENANCE, CALIBRATION, AND/OR REPAIR OF CERTAIN INFORMATION TECHNOLOGY,SCIENTIFIC AND MEDICAL AND/OR OFFICE AND BUSINESS EQUIPMENT—CONTRACTORCERTIFICATION (AUGUST 1996)**

** **

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

 

(a)                                  Thefollowing certification shall be checked:

 

**CERTIFICATION**

 

The offeror certifies ý,does not certify o that: (1) Theitems of equipment to be serviced under this contract are commercial itemswhich are used regularly for other than Government purposes, and are sold ortraded by the Contractor in substantial quantities to the general public in thecourse of normal business operations; (2) The contract services are furnishedat prices which are, or are based on, established catalog or market prices forthe 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 otherverifiable and established record that is regularly maintained by themanufacturer

 

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or the Contractor and iseither published or otherwise available for inspection by customers.  An “established market price” is a currentprice, established in the usual course of ordinary and usual trade betweenbuyers and sellers free to bargain, which can be substantiated by data fromsources independent of the manufacturer or Contractor; and (3) The Contractorutilizes the same compensation (wage and fringe benefits) plan for all serviceemployees performing work under the contract as the Contractor uses forequivalent employees servicing the same equipment of commercial customers.

 

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

 

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

** **

**18.**                               **52.223-4  RECOVEREDMATERIAL CERTIFICATION (OCTOBER 1997)**

** **

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

 

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

** **

**19.**                               **52.223-13  CERTIFICATIONOF TOXIC CHEMICAL RELEASE REPORTING (OCTOBER 2000)**

** **

**NOTE:This certification is applicable for all solicitations for competitivecontracts expected to exceed $100,000 (including all options) and competitive8(a) contracts.  It is not applicable toacquisitions of commercial items, or to contracts where the contractor’sfacilities are located outside the United States (the “United States” includesany state of the United States, the District of Columbia, the Commonwealth ofPuerto Rico, Guam, American Samoa, the United States Virgin Islands, theNorthern Mariana Islands, and any other territory or possession over which theUnited States has jurisdiction)**

 

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

 

(b)                                 Bysigning this offer, the offeror certifies that—

 

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

 

20

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described in section 313of 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) (42U.S.C. 13106), the offeror will file and continue to file for such facilitiesfor 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)                                  Noneof its owned or operated facilities to be used in the performance of thiscontract is subject to the Form R filing and reporting requirements becauseeach such facility is exempt for at least one of the following reasons: (Checkeach block that is applicable.)

 

ý(i)                         The facility does notmanufacture, process, or otherwise use any toxic chemicals listed under section313(c) of EPCRA, 42 U.S.C.  11023(c);

 

o(ii)                      The facilitydoes not have 10 or more full-time employees as specified in section313(b)(1)(A) of EPCRA, 42 U.S.C. 11023(b)(1)(A);

 

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

 

o(iv)                  The facilitydoes not fall within Standard Industrial Classification Code (SIC) major groups20 through 39 or their corresponding North American Industry ClassificationSystem (NAICS) sectors 31 through 33; or

 

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

 

**20.**                               **52.225-2  BUYAMERICAN ACT CERTIFICATE (MAY 2002)**

** **

**[Note:This provision is applicable for all requirements EXCEPT for 1) foreign contractsor 2) when one of the following two provisions (52.225-4, Buy AmericanAct—North American Free Trade Agreement—Israeli Trade Act Certificate, or52.225-6, Trade Agreements Certificate) apply.**

 

21

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(a)                                  Theofferor 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 thissolicitation entitled “Buy American Act—Supplies” and that the offeror hasconsidered components of unknown origin to have been mined, produced, ormanufactured outside the United States. The offeror shall list as foreign end products those end productsmanufactured in the United States that do not qualify as domestic end products.

 

(b)                                 ForeignEnd Products:Line Item No.:Country of Origin:                                                (Listas necessary)

 

(c)                                  TheGovernment will evaluate offers in accordance with the policies and proceduresof Part 25 of the Federal Acquisition Regulation.

** **

**21.**                               **52.225-4  BUYAMERICAN 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 morebut less than $169,000 EXCEPT for 1) foreign acquisitions or 2) acquisitionsthat are exempt from NAFTA and the Israeli Trade Act.  (See FAR 25.401).]**

 

(a)                                  Theofferor 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 clauseof this solicitation entitled, “Buy American Act—North American Free TradeAgreement—Israeli Trade Act”) and that the offeror has considered components ofunknown origin to have been mined, produced, or manufactured outside the UnitedStates.

 

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

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

 

(c)                                  Theofferor shall list those supplies that are foreign end products (other thanthose listed in paragraph (b) of this provision) as defined in the clause ofthis solicitation entitled,  “BuyAmerican Act—North American Free Trade Agreement—Israeli Trade Act.”  The offeror shall list as other foreign endproducts those end products manufactured in the United States that do notqualify as domestic end products.

 

22

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**OtherForeign End Products**

Line Item No.:

Country of Origin:                                                (Listas necessary)

 

(d)                                 TheGovernment will evaluate offers in accordance with the policies and proceduresof Part 25 of the Federal Acquisition Regulation.

** **

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

** **

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

 

(b)                                 Theofferor certifies that the following supplies are Canadian end products as definedin the clause of this solicitation entitled “Buy American Act—North AmericanFree Trade Agreement—Israeli Trade Act”:

**CanadianEnd Products:**

Line Item No.: 

                                                (Listas necessary)

** **

**ALTERNATE II (MAY 2002)**Asprescribed in 25.1101(b)(2)(iii), substitute the following paragraph (b) forparagraph (b) of the basic provision:

** **

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

 

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

 

**Canadianor Israeli End Products**

Line Item No.:

Country of Origin:

                                                (Listas necessary)

** **

**22.**                               **52.225-6  TRADEAGREEMENTS CERTIFICATE - (MAY 2002)**

** **

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

 

(a)                                  Theofferor 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 solicitationentitled “Trade Agreements.”

 

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

** **

**OtherEnd Products**

Line Item No.: 

Country of Origin:

                                                (Listas necessary)

 

(c)                                  TheGovernment will evaluate offers in accordance with the policies and proceduresof Part 25 of the Federal Acquisition Regulation.  For line items subject to the Trade Agreements Act, theGovernment will evaluate offers of U.S.-made, designated country, CaribbeanBasin country, or NAFTA country end products without regard to the restrictionsof the Buy American Act.  The Governmentwill consider for award only offers of U.S.-made, designated country, CaribbeanBasin country, or NAFTA country end products unless the Contracting Officerdetermines that there are no offers for those products or that the offers forthose products are insufficient to fulfill the requirements of thissolicitation.

** **

**23.**                               **52.226-2  HISTORICALLYBLACK COLLEGE OR UNIVERSITY AND MINORITY INSTITUTION REPRESENTATION - (MAY2001)**

 

(a)                                  Definitions.  As used in this provision—

* *

*HistoricallyBlack College or University* means an institution determinedby the Secretary of Education to meet the requirements of 34 CFR 608.2.  For the Department of Defense, the NationalAeronautics and Space Administration, and the Coast Guard, the term alsoincludes any nonprofit research institution that was an integral part of such acollege or university before November 14, 1986.

* *

*MinorityInstitution* means an institution of higher education meetingthe requirements of Section 1046(3) of the Higher Education Act of 1965 (20U.S.C.  1067k, including aHispanic-serving institution of higher education, as defined in Section316(b)(1) of the Act (20 U.S.C. 1101a.)).

 

(b)                                 *Representation.*  The offeror represents that it—

 

ois ý is not a Historically Black College orUniversity; 

ois ý is not a Minority Institution.

** **

**24.**                               **52.227-6  ROYALTYINFORMATION - (APRIL 1984)**

 

(a)                                  **Cost or charges for royalties**.  When the response to this solicitationcontains costs or charges for royalties totaling more than $250, the followinginformation shall be included in the response relating to each separate item ofroyalty or license fee:

 

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(1)                                  Nameand address of licensor.  — See nextpage

 

(2)                                  Dateof license agreement. — See next page

 

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

 

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

 

(5)           Percentage or dollar rate of royaltyper unit.

 

(6)           Unit price of contract item.

 

(7)           Number of units.

 

(8)           Total dollar amount of royalties.

 

25

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(1)                                  Nameand address of licensor

 

[**]

 

(2)                                  Dateof license agreement

 

[**]

 

(3)                                  Patentnumbers, patent application serial numbers or other basis on which the royaltyis payable.  

 

[**].

 

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

 

[**]

 

(5)                                  Percentageor dollar rate of royalty per unit.

 

[**]

 

(6)                                  Unitprice of contract item.

 

$[**]

 

(7)                                  Numberof units.

 

[**]

 

(8)                                  Totaldollar amount of royalties.

 

$[**]

 

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(b)                                 **Copies of current licenses.**  In addition, if specifically requested bythe Contracting Officer before execution of the contract, the offeror shallfurnish a copy of the current license agreement and an identification ofapplicable claims of specific patents.

** **

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

** **

**ALTERNATE I (APRIL 1984), 52.227-6 ROYALTYINFORMATION (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 specialconstruction or special assembly that contain costs or charges for royaltiestotaling more than $250, the following information shall be included in theresponse relating to each separate item of royalty or license fee:

** **

**25.**                               **52.230-1  COSTACCOUNTING STANDARDS NOTICES AND CERTIFICATION (JUNE 2000)**

** **

**Note:**                   **This notice does not apply to small businesses orforeign governments.  This notice is inthree parts, identified by Roman numerals I through III.**

** **

**Offerorsshall examine each part and provide the requested information in order todetermine Cost Accounting Standards (CAS) requirements applicable to anyresultant contract.**

** **

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

** **

**I.**                                         **Disclosure Statement — Cost Accounting Practices andCertification**

 

(a)                                  Anycontract in excess of $500,000 resulting from this solicitation will be subjectto 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)                                 Anyofferor submitting a proposal which, if accepted, will result in a contractsubject to the requirements of 48 CFR Chapter 99 must, as a condition ofcontracting, submit a Disclosure Statement as required by 9903.202.  When required, the Disclosure Statement mustbe submitted as a part of the offeror’s proposal under this solicitation unlessthe offeror has already submitted a Disclosure Statement disclosing thepractices used in connection with the pricing of this proposal.  If an applicable Disclosure Statement hasalready been submitted, the offeror may satisfy the requirement for submissionby providing the information requested in paragraph (c) of Part I of thisprovision.

 

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

 

(c)                                  Checkthe appropriate box below:

 

o(1)                      Certificate of ConcurrentSubmission of Disclosure Statement.

 

The offeror herebycertifies that, as part of the offer, copies of the Disclosure Statement havebeen submitted as follows:

 

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

 

(ii)                                  onecopy to the cognizant Federal auditor.

** **

**(Disclosuremust be on Form No. CASB DS-1 or CASB DS-2, as applicable.  Forms may be obtained from the cognizant ACOor Federal official and/or from the looseleaf version of the FederalAcquisition Regulation).**

 

Date of DisclosureStatement:

 

Name and Address ofCognizant ACO or Federal Official Where Filed:

 

The offeror furthercertifies that the practices used in estimating costs in pricing this proposalare consistent with the cost accounting practices disclosed in the DisclosureStatement.

 

o(2)                      Certificate of PreviouslySubmitted Disclosure Statement.

 

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

 

Date of DisclosureStatement:

Name and Address ofCognizant ACO or Federal Official Where Filed:

 

The offeror furthercertifies that the practices used in estimating costs in pricing this proposalare consistent with the cost accounting practices disclosed in the applicableDisclosure Statement.

 

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o(3)                      Certificate of MonetaryExemption.

 

The offeror herebycertifies that the offeror together with all divisions, subsidiaries, andaffiliates under common control, did not receive net awards of negotiated primecontracts and subcontracts subject to CAS totaling more than $50 million ormore in the cost accounting period immediately preceding the period in whichthis proposal was submitted.  Theofferor further certifies that if such status changes before an award resultingfrom this proposal, the offeror will advise the Contracting Officerimmediately.

 

o(4)                      Certificate of Interim Exemption.

 

The offeror herebycertifies that:

 

(i)                                     theofferor first exceeded the monetary exemption for disclosure, as defined in (3)of this subsection, in the cost accounting period immediately preceding theperiod in which this offer was submitted, and

 

(ii)                                  inaccordance with 48 CFR 9903.202-1, the offeror is not yet required to submit aDisclosure Statement.  The offerorfurther certifies that if an award resulting from this proposal has not beenmade within 90 days after the end of that period, the offeror will immediatelysubmit a revised certificate to the Contracting Officer, in the form specifiedunder subparagraph (c)(1) or (c)(2) of Part I of this provision, asappropriate, to verify submission of a completed Disclosure Statement.

** **

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

 

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

 

If the offeror is aneducational institution that, under the transition provisions of 48 (CFR9903.202-1(f), is or will be required to

 

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submit a DisclosureStatement after receipt of this award, the offeror hereby certifies that ***(check one and complete)****:*

 

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

 

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

 

Nameand Address of Cognizant ACO or Federal Official Where Disclosure Statement isto be Filed:

** **

**II.**                                     **Cost Accounting Standards — Eligibility for ModifiedContract Coverage**

 

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

 

o                                    The offeror herebyclaims an exemption from the Cost Accounting Standards clause under theprovisions of 48 CFR 9903.201-2(b) and certifies that the offeror is eligiblefor use of the Disclosure and Consistency of Cost Accounting Practices clausebecause during the cost accounting period immediately preceding the period inwhich this proposal was submitted, the offeror received less than $50 millionin awards of CAS-covered prime contracts and subcontracts.  The offeror further certifies that if suchstatus changes before an award resulting from this proposal, the offeror willadvise the Contracting Officer immediately.

** **

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

** **

**III.**                                 **Additional Cost Accounting Standards Applicable toExisting Contracts**

 

The offeror shallindicate below whether award of the contemplated contract would, in accordancewith subparagraph (a)(3) of the Cost Accounting Standards Clause, require achange in established cost accounting practices affecting existing contractsand subcontracts.

 

| o  YES |   | o  NO |
|--------|--------|-------|

 

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**26.**                               **CERTIFICATION REGARDING ENVIRONMENTAL TOBACCO SMOKE(DECEMBER 1994)**

** **

**(Note:This certification applies only to those contract which contain provisions forchildren’s services.  The offeror’ssignature on the face page of these Representations and Certificationsconstitutes certification by the submitting organization of its compliance withthe Act.)**

 

Public Law 103-227, also known as the Pro-Children Actof 1994 (Act), requires that smoking not be permitted in any portion of anyindoor facility owned or leased or contracted for by an entity and usedroutinely or regularly for the provision of health, day care, early childhooddevelopment services, education or library services to children under the ageof 18, if the services are funded by Federal programs either directly or throughState or local governments, by Federal grant, contract, loan, or loanguarantee.  The law also applies tochildren’s services that are provided in indoor facilities that areconstructed, operated, or maintained with such federal funds.  The law does not apply to children’sservices provided in private residences; portions of facilities used forinpatient drug or alcohol treatment; service providers whose sole source ofapplicable federal funds is Medicare or Medicaid; or facilities where WIC couponsare redeemed.  Failure to comply withthe provisions of the law may result in the imposition of a civil monetarypenalty of up to $1,000 for each violation and/or the imposition of anadministrative compliance order on the responsible entity.

 

By signing this certification, the offeror/contractor(for acquisitions) or applicant/grantee (for grants) certifies that thesubmitting organization will comply with the requirements of the Act and willnot allow smoking within any portion of any indoor facility used for theprovision of services for children as defined by the Act.

 

The submitting organization agrees that it willrequire that the language of this certification be included in any subawardswhich contain provisions for children’s services and that all subrecipientsshall certify accordingly.

** **

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

** **

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

 

By submission of its offer, the offeror certifiesthat:

 

(1)                                  Awritten and enforced administrative process to identify and manage, reduce oreliminate conflicting financial interest with respect to all research projectsfor which funding is sought from the NIH is o,is not o currently in effect.

 

(2)                                  Shoulda process not be in effect at the time of the submission of its offer, theofferor certifies that it will, no later than 30 days subsequent to submissionof its

 

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offer or prior to award, whichever is earlier, notifythe Contracting Officer of the establishment of a written and enforcedfinancial conflict of interest policy.

 

**28.**                               **15.406-2  CERTIFICATEOF CURRENT COST OR PRICING DATA**

** **

**(Whencost or pricing data are required in accordance with FAR 15.406-2, theContracting Officer will request that the offeror complete, execute, and submitto the Contracting Officer a certification in the format shown in the followingCertificate of Current Cost or Pricing Data. The certification shall be submitted only at the time negotiations areconcluded.  Offerors should complete thecertificate and return it when requested by the Contracting Officer.)**

 

This is to certify that, to the best of my knowledgeand belief, the cost or pricing data (as defined in section 15.401 of theFederal Acquisition Regulation (FAR) and required under FAR subsection15.403-4) submitted, either actually or by specific identification in writing,to the Contracting Officer or to the Contracting Officer’s representative insupportof                                       *are accurate, complete, and current asof                                                     **.

 

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

 

Firm

 

Signature

 

Name

 

Title

 

Date of execution***

 

----

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

 

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

 

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

 

(End of Certificate)

** **

**32**

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** **

**Exhibit 1**

**Exceptions/Restrictions**

 

**Section II.  Information for Vendor; G. Vendor Profile, Experience and References; 3.  References**

Genaissance has generated >3 million genotypes in work that theCompany 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 fromdisclosing details about the genotyping work that the Company has done forthese clients, including the approximate annual aggregate dollar volumeinvolved.

 

**Section III.  General Requirements and Guidelines; H.  Early Termination; 2.  Convenience of the University**

If the University exercises its option to terminate the contractservices under the **Convenience of theUniversity** 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, theCompany would have to issue a press release announcing the award since thedollar amount of the contract would have a material impact on the Company.  Genaissance would provide WSU with anadvance copy of any press release at least five (5) business days prior to thescheduled release.  WSU shall have theright to review expeditiously and recommend changes to any announcementregarding 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 byGualberto Ruaño, M.D., Ph.D., who is a Hispanic American.  Dr. Ruaño was Genaissance’s first ChiefExecutive Officer and is currently the Company’s Chief Scientific Officer, oneof the four executive officers of the Company. Genaissance has developed its proprietary *HAPTM* Technology, which uses specific reagents that areprovided by a limited number of vendors. To minimize costs, the Company does not accept contracts for any workthat it cannot do by itself.  Hence, theCompany does not have any partnering relationships with other firms.  In addition, Genaissance’s *HAPTM* Typing facility, the Company’sgenotyping facility, is CLIA certified and, as such, is prevented fromoutsourcing any of its work.  All of thework in this proposed project would be done in the Company’s *HAPTM* Typing facility.  Hence, none of the work that would be doneunder 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 primaryhigh-throughput genotyping platform. Because the SNP assays are highly multiplexed, the resulting MALDI-TOFspectra are highly complex and are not amenable to manual genotype calling.  Consequently, both Sequenom and Genaissancehave written software to make the initial genotype calls and to perform theanalysis of the data.  Due to the sizeof this project, while the final genotype data can be provided both as a hardcopy and electronically, the raw spectra

 

1

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cannot be provided.  Thesespectra, however, would be available for inspection at Genaissance by the PRBinvestigators.

 

**Section IV.  Statement/Scope of Work. C.  Intellectual Property andPublications.**

If WSU chooses the **Alternate Proposalfor Genotyping (Schedule C)**, then [**] as outlined in **Article 2** of the **License Agreement** in **Addendum2**.

 

**Section V.  Additional Instructions to Vendors - Business Proposals.  A. General Instructions.  d.**

Genaissance does not agree to the statement contained in thissection.  Genaissance would not grantWayne State University and its authorized representative(s) the right toexamine any records of Genaissance.  TheCompany considers its costs to be proprietary information.  There are a number of companies offeringgenotyping services.  Genaissancebelieves that competition in the market place insures that the proposed priceof 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 supplyingsupport for each price proposed.  Thereare a number of companies offering genotyping services.  Genaissance believes that competition in themarket place insures that the proposed price of genotyping will remain highlycompetitive for potential customers.

 

**Section V.  Additional Instructions to Vendors - Business Proposals.  A. General Instructions**

The pricing proposals in **Schedule C**arebased upon the genotyping of a minimum of 4,000 DNA samples.  If WSU decides to have less than 4,000 DNAsamples 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 usfrom 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 orcontrol exclusion for this proposed contract. However, the Company, under its general liability policy, has coveragefor property of other entities while under Genaissance’s control.

 

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**Exhibit 2**

**Profile/Experience/References**

 

**A.**                                    **Profile**

 

Genaissance Pharmaceuticals, Inc. is seeking to create personalizedmedicines 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 aswell as its clinical genetic development skills to identify the genomic markersthat appear to define a patient population that responds best to a medicationand has a superior safety profile. Genaissance markets its technology and predictive genomic markers to thepharmaceutical and biotechnology industries as a means to improve thedevelopment, 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, containingproprietary software for building haplotypes (*HAPTM*Builder) and for detecting associations between gene variation and clinicaloutcomes;

* *

*•*                  *HAPTM*Typing Facility, a CLIA licensed genotyping facility that has generated >3 milliongenotypes; and

 

•                  Association Expertise, consisting ofa high-throughput statistical analysis pipeline.

 

Genaissance has *HAPTM*Technology partnerships with six pharmaceutical and biotechnology companies:AstraZeneca, Biogen, Johnson & Johnson, Millennium, Pfizer, andPharmacia.  In these collaborations andthe Company’s internally funded STRENGTH (**St**atin**R**esponse **E**xami**n**ed by **G**enetic*HAPTM* Markers) clinical trial,Genaissance has used the Company’s *HAP*T*TM*Technology to identify statistically significant associations (p <0.05)between clinical outcomes and *HAPTM*Markers.  The STRENGTH clinical trialwas a prospective, multi-center clinical trial with three parallel arms, eachof which used one of three different statins (atorvastatin, Liptor®;pravastatin, Pravachol®; or simvastatin, Zōcor®).  Genaissance analyzed 176 candidate genes andidentified *HAPTM* Markers thatdefined 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 VicePresident and Chief Technology Officer.

 

Genaissance is not affiliated with any other organizational components,companies or organizations.  There areno Company relationships that could be construed to constitute a conflict ofinterest in doing business with WSU.

 

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On December 16, 2002, Genaissance announced that it had received anotice from General Electric Capital Corporation (GE Capital), claiming anevent of default had occurred under Genaissance’s lease agreement as a resultof an alleged material adverse change in the business of Genaissance.  The GE Capital lease was entered into onApril 10, 1999, prior to the completion of the Company’s Series B and C pre-IPOrounds of financing.  Because of thealleged default, GE Capital has declared that all principal, interest and certainfees, which GE Capital claims to be $3.9 million, are due and payableimmediately.  GE Capital has also fileda complaint in the Superior Court of the State of Connecticut, demandingpayment of all amounts due under the lease agreement.

 

Genaissance does not believe that there has been a material adversechange in the Company’s business and intends to defend itself vigorouslyagainst the GE Capital claims.

 

Genaissance has and will continue to pay all of the Company’s debtobligations.  Genaissance currently owesits 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 GECapital claim, the Company may be required to pay its lease creditors soonerthan was originally scheduled.  Paymentin 2003 of all outstanding principal and interest with its lease creditorswould have the effect of increasing the Company’s cash burn by approximately $3million in fiscal 2003, with an offsetting reduction in cash payments in fiscal2004.  The Company projects that it willend fiscal 2002 with a balance of cash, cash equivalents and marketablesecurities totaling at least $33 million, which Genaissance believes issufficient to meet the company’s goal of cash breakeven in 2005.

 

Genaissance, founded in April 1997, went public in August 2000 and istraded 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, and2002, respectively.  Genaissanceoccupies 78,000 square feet of space in Science Park in New Haven, Connecticutand currently has 105 employees.

 

**B.**                                    **Experience**

 

Genaissance discovers polymorphisms by sequencing genes in a panelconsisting of 93 individuals from the Company’s Index Repository, and achimpanzee and a gorilla.  TheGenaissance *HAPTM* Factory, thename given to the Company’s sequencing facility, has 59 ABI Prism® DNAAnalyzers.  To date, Genaissance hasgenerated [**] sequence reads.  Duringthe one-year period from March 31, 2001 through March 30, 2002, the Companygenerated [**] sequence reads, 83% of which met the Company’s stringent qualitycontrol criteria, i.e. a phred score >30.  The Company considers a DNA fragment to be completely sequencedif 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 primerpairs that did not amplify DNA fragments well or primers that yielded a mixtureof amplimers.  To date, Genaissance hasexamined 7,287 genes in the Company’s *HAPTM*Factory, identified 134,142 SNPs and organized these SNPs into 137,208haplotypes.  Genaissance recentlypublished a paper describing the genetic diversity that the

 

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Company discovered in 313 genes (Stephens, J.C. *et al*. 2001.  “Haplotype Variation and Linkage Disequilibrium in 313 HumanGenes.” 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-throughputgenotyping projects.  During thesix-month period from October 1, 2001 through March 31, 2002, Genaissancegenerated >[**] million genotypes. During the four most productive weeks in this period of time, more than[**] genotypes were generated.  During2002, the facility generated approximately [**] million genotypes.  To date, the Company has generated a totalof more than 3.0 million genotypes.  Thecurrent annual capacity of the Genaissance *HAPTM*Typing Facility is [**] million genotypes. In the current genotyping process, generally 75% of the SNPs, for whichassays are designed, become validated for production use.  The remaining 25% of SNPs, which failed afirst attempt at assay development, are recycled for assay development,yielding similar success rates. Essential, but recalcitrant SNPs, which fail two attempts for assaydevelopment on the Sequenom platform, are subjected to two additional assay developmentcycles on an alternate genotyping platform (Pyrosequencing and/orTaqMan®).  Using this procedure forassay development, the Company’s assay conversion rate for essential SNPsapproaches 100%.  In a single pass ofgenotyping, these production-quality assays generate on average greater than90% of the total possible data.  On aper project basis, greater than 95% of the total possible data is generated.

 

Between these two production facilities, Genaissance has performedhigh-throughput genotyping and sequencing projects for both internally andexternally funded projects.  The Companyhas extensive experience in simultaneously managing the logistics of multiplelarge-scale projects, including sample handling, assay development, production,data collection, quality control, data analysis, data transmittal andreporting.  The *HAPTM* Typing Facility is CLIA licensed andfollows GLP and GCP practices (21 CFR part 58), thus providing assurance forthe 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 thegenotyping work that has been performed.

 

2.                                       [**]

 

Genaissance has provided genotyping services for [**]does not permit Genaissance to disclose the nature or the magnitude of thegenotyping work that has been performed.

 

3.                                       [**]

 

Genaissance has provided genotyping services for[**]does not permit Genaissance to disclose the nature or the magnitude of thegenotyping work that has been performed.

 

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**Exhibit 3**

**Vendor Service Plan**

** **

**A.**                                    **General Requirements**

 

1.                                       **Requirement:**  The VENDOR shall provide detailed quality control and qualityassurance (QA/QC) plans.  These shouldcover sample handling, labeling and storage, as well as genotyping.  Detail on how the VENDOR will avoidmislabeling of samples during genotyping is particularly important.

 

**Response:**

 

a.                                       Samplehandling, labeling and storage. This proposed genotyping project will be performed in GenaissancePharmaceutical’s 8,000 square foot CLIA licensed *HAP*TM Typing Facility(Centers for Medicare and Medicaid Services CLIA license: 07D0995237;Connecticut Department of Public Health CLIA license: CL-0633) and will followCLIA, GLP and GCP laboratory standards. The entire project, starting with sample receipt and ending with datatransmittal, will be performed in accordance with the Company’s establishedlaboratory protocols and SOPs.  Theprotocols, SOPs and other documentation are available for inspection in the *HAP*TMTyping Facility at Genaissance Pharmaceuticals.

 

DNA Samples will be received in the Genaissance *HAP*TMTyping Facility’s receiving laboratory. All plates will be labeled with barcodes and accessioned using theGenaissance *HAP*TMTyping Facility’s LIMS (Laboratory Information Management System).  While the laboratory is not 21 CFR part 11compliant, due to the use of vendor supplied equipment software originatingfrom multiple sources, the LIMS that the Company developed was written in amanner consistent with these regulations. Each DNA sample is given a unique identifier that will be associatedwith all daughter and experimental plates and tracked, using the LIMS, throughall aspects of the genotyping process. Once the original master plates have been accessioned, small aliquotswill be removed for QC testing, which includes determination of DNAconcentration, OD260/OD280 ratio, DNA integrity andfunctional PCR analysis.  Once the DNAconcentration has been determined for each sample, a Tecan GENESIS worklistwill be written to create a master working plate containing the DNA at theappropriate concentration.  The originalbarcode labeled master plates will be stored at -70°C and trackedelectronically.  Upon completion of theproject, the master plates will be returned to WSU.  The master working plates will be used to create barcode labeledsingle use plates.  The single useplates will be stored at 4°C until they are used.

 

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b.                                      Genotyping.

 

i.                                          *Summary*. Genaissance currently performs high-throughput genotyping on Sequenom’sMassARRAY*TM* platform using thehomogeneous Mass EXTENDTM, process. Analysis is performed on a 384-spot silicon chip (SpectroCHIP) with upto [**] SNP assays multiplexed per spot. Process improvements and experience now allow the *HAPTM* Typing Facility to do a single genotyperun and generate, on average, greater than 95% of the total possible data with>99.8% accuracy.  To manage the largeamount of data that the *HAPTM*Typing Facility is capable of producing, an integrated LIMS monitors allaspects of the Company’s laboratory operations, starting with sample receiptand finishing with data transmittal. Genaissance’s high-throughput genotyping process is outlined below.

 

ii.                                       *Assay Design*.  For contract service work, Genaissance requires the customer tosupply the HUGO symbol for the genes of interest.  Public domain SNPs will be selected from these genes.  Alternatively (see **Schedule C: Alternate Proposal**), using therequested gene list and the Company’s internally identified and validatedproprietary SNPs, Genaissance can select SNPs and design assays to capture 380% of the genetic diversity for the given gene.  These SNPs were discovered in Genaissance’s *HAPTM* Factory through gene-based sequenceanalysis of 82 unrelated individuals. These validated SNPs provide the highest quality starting material forassay development and an internal control for independent validation ofgenotyping assays.  Using thesevalidated SNPs and proprietary enhancements to the MassARRAY*TM* process, a test is now designed toconsist of up to twenty multiplexed assays using a combination of Sequenom’sSpectroDesignerTM Software and the Company’s own proprietary assay designsoftware.  Complexity levels are drivenby the number of SNPs queued for assay design. As the number of SNPs queued for assay design increases, so does thefinal complexity level of the resulting tests.

 

iii.                                    *Assay Validation*.  For projects consisting of a large number ofDNA samples (>384), Genaissance uses a two-step validation procedure.  Once oligonucleotides have passed qualitycontrol, the tests are run on a small number of control samples.  [**] controls (ethnically matched to theexperimental DNA samples) from the Company’s Index Repository serve to validatethe assay through a comparison of the results obtained with the Sequenomplatform and the results, if available, obtained previously by sequencingduring the *HAPTM* Marker discoveryprocess.  If there is a discrepancybetween the results from the two different assay platforms, or if an assay doesnot generate a sufficient numbers of

 

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genotyping calls, then that under performing assay isremoved from the test and redesigned. Subsequently, the assays are continuously validated in production.  This is achieved through maintaining thesame control samples on the production plate. If the SNP, for which the Company is asked to design an assay, is onethat has not been identified in Genaissance’s *HAPTM*Marker discovery process, the Company requires that the client provideGenaissance with a DNA control sample, i.e. a genomic DNA sample that containsthe less frequent SNP allele.  In thismanner, Genaissance can validate the SNP assay.  At the customer’s request, Genaissance will use an unvalidatedassay 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)   |   | [**]                    |   | [**]             |   | [**]                                  |   | [**] |   | [**] |   | [**] |   | [**] |   |

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Compiled Genotypes: genotypes assembled from two or more plates.STD: standard deviation

[**]

 

v.                                      *Rules for Genotyping*.  Given the above process changes andimprovements, Genaissance now uses the following set of rules for processingsamples in the Company’s *HAPTM*Typing Facility.

 

•                                          Alltests will be designed for maximum permissible complexity (currently[**]-plexes).

 

•                                          Assayresults for positive controls will be checked for concordance with *HAP*TMMarker discovery results.  Assaysfailing this consistency check will be removed from production andredesigned.  For assay requests thatcannot be mapped to the Company’s database, the customer must provide a controlgenomic DNA sample containing the rare

 

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allele.  Withoutsuch a control, the assay cannot be validated. However, upon the request of the client, Genaissance will put anunvalidated assay into production.

 

•                                          Assayresults will be checked for deviation from Hardy-Weinberg equilibrium.  Assays that produce results that deviatesignificantly from the expected distribution will be flagged for review.

 

•                                          Assaysthat generate 3 [**]% of the possible data from a singlegenotype run will be considered to be finished (see **Evaluating the Consequences of Using the Rules** below) and thedata will be considered complete.

 

•                                          Assaysthat generate [**]% of the total possible data will be requeued for a secondgenotype run.

 

•                                          Thoseassays that generate £ [**]% of the totalpossible data with a single genotype run or fail to generate 3[**]% of the total possible data after combining the results from two genotyperuns will be redesigned.

 

•                                          Thesecond iteration for an assay will follow the same rules as the first exceptthat assays failing the above criteria will not be redesigned and the assayswill be terminated.  If the clientdesignates such SNPs to be essential, the assay will be redesigned for anadditional cost on an alternate platform. Genaissance currently uses Pyrosequencing and TaqMan® as alternateplatforms.

 

vi.                                   *Evaluating the Consequences of Using the Rules*.  Genaissance has evaluated this set of rules *in silico* by applying the Rules to dataalready produced under the previous production paradigm.  Below is a summary of the results from thisanalysis.

 

[**][**] (**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%) |   |

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Total Number of Subjects: 360STD: standard deviation

 

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Originally, there weretwo main reasons for processing samples in duplicate.  The first reason was to insure accuracy by checking consistencybetween multiple runs.  The secondreason was to maximize the number of samples for which the Company would obtaina genotype.  This analysis demonstratesthat the fraction of correct calls obtained with a single genotype run is>[**]% (**Table II**).  Also, by following these **Rules**, Genaissance will obtain results forat least [**]% of the samples but the average coverage is likely to be significantlyhigher (for example, [**]%, **Table II**).

 

The use of haplotypes isparticularly important for obtaining genotyping results at the lowest possiblecost.  During haplotype assignment,missing genotypes are statistically inferred. The fraction of correctly inferred genotypes during haplotype assignmentdepends only on allele frequencies and the extent of redundant informationfound in other SNPs.  This rate ranges,theoretically, from a worst case of 50% (when there is no redundant informationand the two SNP alleles are equally frequent) to nearly 100% accurate genotypeinference.  Based on the **Rule** of >[**]% coverage, this means thatgenotypes represented in haplotype assignments would be [**]% accurate in theworst case.  However, because our singlegenotype coverage is predicted to be very high, in the test case it was [**]% (**Table II**), and allele frequencies areusually far from equal, the effective genotype accuracy after haplotypeassignment should average close to [**]% for the single plate analysis and[**]% with redundancy.  Adjusting forincorrect genotypes produces a final estimate of average accuracy between [**]%and [**]%, respectively.  This accuracyis more than sufficient to build haplotypes and detect significantassociations.  An overview of the entireR&D process is shown in **Figure 1**.

 

vii.                                *Rule Conclusions*.  Application of these **Rules** does not significantly change theamount of missing genotype data or potentially erroneous genotype calls and,consequently, does not significantly impact the Company’s ability to build andassign haplotypes.  This process has hadno impact on the Company’s ability to detect an association between a phenotypeand genetic variation.  Also, becausedata is generated from a single production plate, the amount of DNA needed hasbeen effectively cut in half.

 

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For clients that require either duplicate data or ahigher 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 LaboratoryDirector.  Some customers have requestedthat the data and report also be supplied via email for quicker delivery.

 

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For this proposed project, data can be transferredweekly, monthly, or at other intervals as requested.

 

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

** **

**Response:**  All of the information requested above, ispart of Genaissance’s SOP. Additionally, a DNA sample QC report will be provided.  Typically, this report is provided uponcompletion of the QC process and prior to initiation of genotyping.  However, this report can be transmitted tomeet the customer’s needs.

 

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

** **

**Response:** This information hasbeen provided in detail in **Section A.1**above.  See below for an example of Genaissance’sLIMS data export.  These exports aretypically transmitted as a standard flat text file.  As many customers require data in specific formats, Genaissanceroutinely creates scripts designed to reformat data to meet the needs of thecustomer.

 
| 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       |   |

 

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**B.**                                    **The VENDOR shall provide the following services:**

 

1.                                       **Requirement:**  Provide the PRB investigators designated by WSU with haplotypeand allele frequency information for polymorphisms in the candidate genes fromdifferent ethnic groups, and assist in identifying suitable polymorphisms forthe study.

** **

**Response:**  This service will be provided for publicdomain SNPs as outlined in **Schedule C**.  Alternatively, WSU may elect to useGenaissance 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 assaydesign and success rates.

** **

**Response:**  Genaissance’s assay design process isoutlined in detail in **Exhibit 2**, **Section B**, **Experience** and in **Exhibit 3**,**Section A**, **General Requirements**, **Subsection b**, **Genotyping**.  Aflowchart of Genaissance’s genotyping process, including assay design, is shownin **Figure 1**.  When using the Company’s proprietary SNPs,Genaissance has successfully converted >90% of the polymorphisms tofunctional validated assays.

 

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

** **

**Response:**  Genaissance has successfully performedgenotyping using whole genome amplified DNA samples.  Genaissance does not expect to encounter difficulties inusing theWSU DNA samples.  A detailed discussionof the Company’s genotyping process is provided in **Exhibit 2, Section B, Experience and in Exhibit 3, Section A, GeneralRequirements, Subsection b., Genotyping**.

 

4.                                       **Requirement:**  Input the genotyping data into database tables with a structurespecified by WSU

** **

**Response:**  Genaissance routinely reformats genotypingdata to meet the needs of the customer.

 

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

** **

**Response:**  As part of the Company’s SOPs, Genaissancevalidates all assays using a set of control samples, prior to putting theassays into production use.  Many ofthese control samples are also used on the production plate along with negativecontrols.  The assays to be repeated caneither be randomly selected by Genaissance’s QA/QC officer or by the PRBinvestigators.

 

6.                                       **Requirement:**  Provide WSU with all the raw data (including gel images or otherelectronic data) as hard copies and in electronic format.

** **

**Response:**  Genaissance uses the Sequenom MassARRAY*TM* platform as its primary high-throughputgenotyping platform.  Because the SNPassays are highly multiplexed, the resulting MALDI-TOF spectra are highlycomplex and are not amenable to manual genotype calling.  Consequently, both Sequenom and Genaissance havewritten software to make the initial genotype calls and to perform the analysisof the data.  Due to the size of thisproject, while the final genotype data can be provided both as a hard copy andelectronically, the raw spectra cannot be provided.  These spectra, however, would be available for inspection atGenaissance by the PRB investigators.

** **

**9**

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** **

**Exhibit 4**

**Vendor Qualifications**

 

**From RFP**: “You arerequested to submit a summary of your General Experience, OrganizationalExperience Related to this RFP, Performance History, Pertinent Contracts andGrants.  This information should beprovided in your Proposal under “**VendorExhibit 4**”, Vendor Qualifications.

 

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

** **

**Response:**GenaissancePharmaceuticals, Inc. is seeking to create personalized medicines through theintegration of gene variation into drug development.  The Company discovers inherited differences, or genomic markers,that exist in human genes.  Genaissanceuses the Company’s technological capabilities and methods as well as itsclinical genetic development skills to identify the genomic markers that appearto define a patient population that responds best to a medication and has asuperior safety profile.  Genaissancemarkets its technology and predictive genomic markers to the pharmaceutical andbiotechnology industries as a means to improve the development, marketing andprescribing 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, containingproprietary software for building haplotypes (*HAPTM*Builder) and for detecting associations between gene variation and clinicaloutcomes;

* *

*•*                  *HAPTM* Typing Facility, a CLIA licensedgenotyping facility that has generated >3 million genotypes; and

 

•                  Association Expertise, consisting ofa high-throughput statistical analysis pipeline.

 

Genaissance has *HAPTM*Technology partnerships with six pharmaceutical and biotechnology companies:AstraZeneca, Biogen, Johnson & Johnson, Millennium, Pfizer, andPharmacia.  In these collaborations andthe Company’s internally funded STRENGTH (**St**atin**R**esponse **E**xami**n**ed by **G**enetic***H****APTM* Markers) clinical trial, Genaissancehas used the Company’s *HAPTM*Technology to identify statisticallysignificant associations (p <0.05) between clinical outcomes and *HAPTM* Markers.  The STRENGTH clinical trial was a prospective, multi-centerclinical trial with three parallel arms, each of which used one of threedifferent statins (atorvastatin, Liptor®; pravastatin, Pravachol®; orsimvastatin, Zōcor®).  Genaissanceanalyzed 176 candidate genes and identified *HAPTM*Markers that defined patient populations, which responded differently to thethree statins.

 

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Genaissance, founded in April 1997, went public in August 2000 and istraded on the Nasdaq National Market under the symbol GNSC.  Genaissance occupies 78,000 square feet ofspace in Science Park in New Haven, Connecticut and currently has 105employees.

 

Based on the proposed size of the project (4,000 DNA samples, 800 SNPassays and 30% repeat genotypes for QC purposes) and the proposed turnaroundtime of the project (20 weeks), Genaissance’s *HAP*TM Typing facility will devote[**]% of its capacity to the proposed project.

 

“2.                                 “Organizationalexperience” 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 corporateexperience, BUT NOT the experience and/or past performance or individuals whoare proposed as personnel involved with the Statement of Work in this RFP.”

** **

**Response**:Genaissance discovers polymorphisms by sequencing genes in a panel consistingof 93 individuals from the Company’s Index Repository, and a chimpanzee and agorilla.  The Genaissance *HAPTM* Factory, the name given to theCompany’s sequencing facility, has 59 ABI Prism® DNA Analyzers.  To date, Genaissance has generated[**]sequence reads.  During the one-yearperiod from March 31, 2001 through March 30, 2002, the Company generated [**]sequence reads, 83% of which met the Company’s stringent quality controlcriteria, i.e. a phred score 330.  The Company considers a DNA fragment to becompletely sequenced if sequence information is obtained for at least 85% ofthe DNA samples.  Information wassuccessfully generated for [**]% of the DNA fragments sequenced during thisinterval of time.  Failures were usuallythe result of primer pairs that did not amplify DNA fragments well or primersthat yielded a mixture of amplimers.  Todate, Genaissance has examined 7,287 genes in the Company’s *HAPTM* Factory, identified 134,142 SNPs andorganized these SNPs into 137,208 haplotypes. Genaissance recently published a paper describing the genetic diversitythat the Company discovered in 313 genes (Stephens, J.C. *et al*. 2001. “Haplotype Variation andLinkage 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 MassARRAY*TM*platform for high-throughput genotyping projects.  During the six-month period from October 1, 2001 through March31, 2002, Genaissance generated >[**] million genotypes.  During the four most productive weeks inthis period of time, more than [**] genotypes were generated.  During 2002, the facility generatedapproximately [**] million genotypes. To date, the Company has generated a total of more than 3.0 milliongenotypes.  The current annual capacityof the Genaissance *HAP*TM Typing Facility is [**] million genotypes.  In the current genotyping process, generally75% of the SNPs, for which assays are designed, become validated for productionuse.  The remaining 25% of SNPs, whichfailed a first attempt at assay development, are recycled for assaydevelopment, yielding similar success rates. Essential, but recalcitrant SNPs, which fail two attempts for assaydevelopment on the Sequenom platform, are subjected to two additional assaydevelopment cycles on an alternate genotyping platform (Pyrosequencing and/orTaqMan®).  Using this procedure forassay development, the Company’s assay conversion rate for essential SNPsapproaches 100%.  In a single pass ofgenotyping, these production-quality assays generate on

 

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average greater than 90% of the total possible data.  On a per project basis, greater than 95% ofthe total possible data is generated.

 

Between these two production facilities, Genaissance has performedhigh-throughput genotyping and sequencing projects for both internally andexternally funded projects.  The Companyhas extensive experience in simultaneously managing the logistics of multiplelarge-scale projects, including sample handling, assay development, production,data collection, quality control, data analysis, data transmittal andreporting.  The *HAPTM* Typing Facility is CLIA licensed andfollows GLP and GCP practices (21 CFR part 58), thus providing assurance forthe production of the highest quality genotyping data.

 

“3.                                 “Performancehistory” is defined as meeting contract objectives within DELIVERY and PRICESCHEDULES on efforts, either past or on-going, which is comparable or relatedto the efforts required by this RFP.”

** **

**Response**: Genaissanceis not permitted to discuss details of the contracts in place with AstraZeneca,Biogen, Johnson & Johnson, Millennium, Pfizer, Pharmacia, and Sciona.

 

“4.                                 “Pertinentcontracts” is defined as a listing of each related contract completed withinthe 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 thespecified period of time.

 

“5.                                 “Pertinentgrants” - list grants supported by the Government that involve similar orrelated work o (sic) that called for in this RFP.  Include the grant number, involved agency, names of the grantspecialist and the Science Administrator, identification of the work, and whenperformed.”

** **

**Response**: NotApplicable.

 

“6.                                 “Facilities”- provide a description of the facilities that the VENDOR proposes to use, inthe performance of this contract.  Thedescription should include a statement as to whether the facility meets P3 orP4 requirements.”

 

This proposed genotyping project will be performed in Genaissance’s8,000 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) andwill follow CLIA, GLP and GCP laboratory standards.  Because Genaissance uses Epstein-Barr virus to create transformedcell lines, the Company’s Index Repository meets and follows Biosafety Level 2guidelines.  All of Genaissance’sfacilities follow applicable state and federal biosafety guidelines.

 

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**Exhibit 5**

**Small Business Subcontracting Plan**

** **

Genaissance meets thedefinition of a small business. Genaissance has developed its proprietary *HAPTM* Technology, which uses specific reagents that areprovided by a limited number of vendors. To minimize costs, the Company does not accept contracts for any workthat it cannot do by itself.  Hence, theCompany does not have any partnering relationships with other firms.  In addition, Genaissance’s *HAP*TMTyping facility, the Company’s genotyping facility, is CLIA certifiedand, as such, is prevented from outsourcing any of its work.  All of the work in this proposed projectwould be done in the Company’s *HAPTM*Typing facility.  Hence, none of thework that would be done under this proposed project could be partnered withanother company.

 

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Genaissance Confidentialand Proprietary

 

**Terms and Conditions**

 

1.                                       **General**. For purposes hereof:

* *

*Assay Data*meansthe genotypes, haplotypes and related data generated by Genaissance from WSUpatient samples as set forth in the “Proposal for Wayne State University inresponse to RFP - Genotyping” and dated January 9, 2003 (hereinafter “TheResponse”).*Client*shall mean WSU.

 

*Genaissance*shallmean Genaissance Pharmaceuticals, Inc.

* *

*Services*shallmean all genotyping and other services to be performed by Genaissance forClient as set forth in The Response.

* *

*Research Use*meansthe use of Assay Data for research purposes only and specifically excludes useof Assay Data by Client to perform services for a third party other than PRBand any and all diagnostic, therapeutic or clinical uses.

 

These Terms and Conditions, all attached schedules and exhibits, ifany, (collectively, the “Agreement”), will exclusively govern Genaissance’sprovision of Services to Client. Client’s acceptance of any quotation for Services is subject to andexpressly limited by these Terms and Conditions.  These Terms and Conditions cannot be waived, modified orsupplemented without the prior, express written consent of Genaissance.

 

2.                                       **Services**. Genaissance will use reasonable commercial efforts to perform theServices described in The Response pursuant to the specifications and timelineset forth therein and subject to these Terms and Conditions and such otherconditions 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 Conditionsand the Schedules attached hereto, Genaissance makes no representations,warranties or guarantees regarding the Assay Data supplied by Genaissance toClient, or the use of, or the results of the use of such Assay Data, or theperformance of the Services. GENAISSANCE AND ITS SUPPLIERS DISCLAIM ALL OTHER WARRANTIES, WHETHEREXPRESSED OR IMPLIED, INCLUDING, WITHOUT LIMITATION, IMPLIED WARRANTIES OFMERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT.  Client’s exclusive remedy underGenaissance’s warranty is, at Genaissance’s sole option, a credit for orre-performance of the Services in question. IN NO EVENT WILL GENAISSANCE OR ITS SUPPLIERS BE LIABLE FOR ANYCONSEQUENTIAL, INCIDENTAL, SPECIAL OR INDIRECT DAMAGES, INCLUDING WITHOUTLIMITATION, DAMAGES FOR LOSS OF PROFITS, BUSINESS INTERRUPTION, LOSS OFBUSINESS INFORMATION OR PROPERTY DAMAGE SUSTAINED BY CUSTOMER FROM THE USE OFOR INABILITY TO USE ANY ASSAY DATA, EVEN IF GENAISSANCE HAS BEEN ADVISED OF THEPOSSIBILITY OF SUCH

 

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DAMAGES.  AS TO ANY GENAISSANCELIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING, GENAISSANCE’S MAXIMUM LIABILITYWILL NOT EXCEED THE AGGREGATE AMOUNT PAID BY CLIENT TO GENAISSANCE FOR THESERVICES 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 Datain addition to the technical assistance, advice and information specified inThe Response, if and to the extent that such advice, assistance and informationis conveniently available.  Suchinformation is provided [**], subject to the warranty disclaimers set forth inparagraph 6.[**]

 

6.                                       **Intellectual Property; Secrecy**.  Client represents and warrants that anyinformation, technology, supplies, specifications, designs and materials itsupplies to Genaissance to enable Genaissance to provide to Client any Services(collectively, “Client Information”) will not infringe the intellectualproperty rights of any third parties. All intellectual property rights in the technology used to perform theServices will at all times remain vested in Genaissance.  Any proprietary know-how or otherinformation disclosed by Client to Genaissance in connection with the provisionof Services, as well as any Assay Data supplied to Client by Genaissance, otherthan *HAP*TMMarkers, will remain the sole property of Client and will not be used ordisclosed by Genaissance to any third party without Client’s prior writtenconsent, except where such use or disclosure is necessary to properly carry outthe provision of the Services in question or for Genaissance to practice anyresearch license granted by WSU pursuant to Section 2 of the License AgreementAddendum.  Client will not use ordisclose to any third party any confidential or proprietary information ofGenaissance without Genaissance’s prior written consent, except as expresslyauthorized in these Terms and Conditions or the License AgreementAddendum.  The following types ofinformation will not be subject to the foregoing secrecy provisions: (i)information which is or becomes publicly available; (ii) information which islawfully obtained by the receiving party from a third party; and (iii)information which is required to be disclosed by a legal or regulatoryauthority.  Client acknowledges thatGenaissance designs and performs genotyping assays and other services for thirdparties.  Client further acknowledges andagrees that Genaissance intends and is permitted to sell and otherwisecommercialize to third parties such genotyping assays (with no obligation toClient) that may be utilized or generated as a result of or during theperformance by Genaissance of Services other than the Assay Data.  This paragraph 6 will survive anytermination or expiration of the Agreement.

 

7.                                       **Limited License**.  All Assay Data delivered hereunder are solely for researchuse.  Client is specifically notauthorized to use any Assay Data for diagnostic or therapeutic purposes or asdirect components in the manufacture or use of any diagnostic or therapeuticproduct, or to provide any services to any third party other than PRB forcompensation.  No other right isintended or granted through the provision of any Services to Client byGenaissance.  Purchase by Client ofServices does not include or carry any right of Customer to any Genaissancetechnology or intellectual property except as explicitly provided in theIntellectual Property Addendum.

 

8.                                       **Indemnity**. Except where the claim, loss or liability (collectively, “Losses”)arises as a result of the gross negligence or willful misconduct ofGenaissance, Client indemnifies Genaissance, its agents, employees, directors,affiliates and representatives (“Genaissance Indemnified Party”) from andagainst any Losses which may be incurred by an Genaissance Indemnified Party asa result of or arising in connection with (i) Client’s use or transfer to third

 

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parties of any Assay Data and (ii) any alleged infringement by Clientof the proprietary rights of a third party as a result of use of the Assay Databy Client or by any such transferee of Client.

 

9.                                       **Insolvency**.  In the event that Client becomes insolvent, bankrupt underapplicable law or otherwise becomes unable to repay its debts, Genaissance mayimmediately terminate its provision of Services under these Terms andConditions without notice in addition to any other rights or remedies availableto Genaissance.

 

10.                                 **Force Majeure**.  Genaissance will not be liable for nonperformance of any of itsobligations hereunder or to perform any Services to the extent that suchperformance is prevented, prohibited or delayed by any circumstance for reasonsbeyond its control including, without limitation, strikes, lock-outs or labordisputes, fire, flood, natural disaster, war, blockade, military operations,riot, civil commotion, plant breakdown, power outage, and computer or otherequipment failure, provided that Genaissance completes the contract within areasonable time after the circumstances are resolved.

 

11.                                 **Agents**. No agent, employee or other representative has the right to modify orexpand Genaissance’s standard warranty applicable to Services or to make anyrepresentations concerning Services other than those set forth in Genaissance’smarketing or technical literature.  Anysuch affirmation, representation or warranty, if made, should not be reliedupon by Client and does not form a part of The Response or these Terms andConditions.

 

12.                                 **Modifications, Waiver**.  These Terms and Conditions may be modifiedand any breach thereunder may be waived only by a writing signed by bothGenaissance and Client.

 

13.                                 **Assignment**.  Client may not assign these Terms and Conditions or any of itsrights to Services hereunder without the prior, express written consent ofGenaissance.  Any change of control ofClient 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 orportion thereof is found to be illegal or unenforceable, it shall be construedwithout the unenforceable provision or portion thereof.

 

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**[Attachment 5]**

** **

**CONFIDENTIAL**

** **

**ADDENDUM TO SCHEDULE C OF PROPOSAL**

** **

This Addendum is hereby incorporated by reference and made a part ofthe attached Schedule C agreed upon by Wayne State University (“Client”) andGenaissance 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-deepwell plates.  Genaissance will performthe 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, butshall charge WSU only for delivered genotypes as follows.

 

If WSU sends Genaissance at least [**] samples, the base genotyping feeis $[**] per delivered genotype.  If WSUsends Genaissance less than [**] samples, the base genotyping fee is $[**] perdelivered genotype.  These basegenotyping fees are for a combination of certain numbers of DNA samples sentfor genotyping with certain numbers of SNP assays.  In this way, the samples can be processed on Genaissance’sgenotyping platform in the most efficient manner.  Thus, surcharges will apply if the number of SNP assays is lessthan [**] or if the number of DNA samples in any batch of samples (consistingof 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 [**]                       |   | $                                     | [**]   |   |

 

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**Sample Size Surcharge**:  Genaissance uses a 384-position format, inwhich [**] of the positions are occupied by samples and [**] of the positionsare 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 anyduplicate samples) that is [**], perform the following steps to determine thesurcharge to be applied [**]:

 

•                  [**]

 

**Example 1**:  WSU requests that Genaissance genotype [**]DNA samples with [**] SNP assays.

 

•                  [**]

** **

**Example 2** (Forillustrative purposes only):

 

The maximum price that WSU would pay for different numbers of DNAsamples is shown below.  In eachinstance, 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 |   |
|                            |                                       |  |  |  |  |  |  |

 

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**[Attachment6]**

** **

**CONFIDENTIAL**

** **

**ADDENDUMTO ADDENDUM 1 (TERMS AND CONDITIONS) OF PROPOSAL**

** **

This Addendum is hereby incorporated by reference andmade a part of the attached Terms and Conditions agreed upon by Wayne StateUniversity (“Client”) and Genaissance Pharmaceuticals, Inc. (“Genaissance”).

 

[**]

 

“WSU agrees to pay Genaissance the price of Servicesas quoted by Genaissance in the Addendum to Schedule C for each genotypedelivered.  Payment terms are [**].  All payments will be made in United StatesDollars.  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 orinvoiced.  In the event that Genaissanceis required to prepay any such tax or fee, all such fees will be prepaid byGenaissance and added to the invoice. The parties acknowledge that Client is tax-exempt.”

 

[**]

 

“**Termination**.  In the event Client wishes to terminateServices provided by Genaissance hereunder, Client shall reimburse actualexpenditures by Genaissance for all materials purchased by Genaissancespecifically for performing Services, the results of which were not deliveredto Client prior to the effective date of such termination, but in no eventshall Client provide such reimbursement in excess of $[**].  In order to receive reimbursement under thisSection 15, Genaissance must provide adequate documentation of anyexpenditure.  Any unused materials forwhich Client has provided reimbursement pursuant to this Section 15 shallbecome Client’s sole property immediately upon payment and shall be promptlydelivered to Client by Genaissance, with due regard to the expiration of anytime-sensitive material.”

 

[**]

 

“**DisputeResolution**.  The partieshereby agree that they will attempt in good faith to resolve any controversy orclaim arising out of or relating to this Agreement promptly bynegotiations.  If a controversy or claimshould arise hereunder, the matter shall be referred to an individualdesignated by the Chief Executive Officer (or the equivalent position) ofGenaissance and an individual designated by the President (or the equivalentposition) of WSU (the “Representatives”). If the matter has not been resolved within [**] ([**]) days of the firstmeeting of the Representatives of the parties (which period may be extended bymutual agreement) concerning such matter, each party may pursue available legalor equitable remedies.”

 

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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 |

 

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**[Attachment7]**

** **

**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., withits 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 partyand collectively as the parties.

 

**RECITALS**

** **

WHEREAS, WSU has a service contract with thePerinatology Research Branch (PRB) of the National Institute of Child Healthand Human Development (NICHD) that includes the identification of geneticvariants that predispose individuals to a normal or abnormal pregnancy outcome(the “PRB Contract”);

 

WHEREAS, Genaissance has expertise in integrating andapplying population genomics and informatics to the identification ofcorrelations between genetic variants and clinical phenotypes such as diseaseassociations and drug response, which expertise includes its proprietary *HAPTM* Database of gene specific variants (“*HAPTM* Markers”, as hereinafter defined) andits 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 andGenaissance have concurrently herewith entered into a contract pursuant towhich WSU will gain access to certain *HAP*Markers and to the *DecoGen*InformaticsSystem, and pursuant to which Genaissance will provide genotyping services (the“Genotyping Contract);

 

WHEREAS, WSU is interested in obtaining a license touse the *HAP*Markers and *DecoGen®* InformaticsSystem for certain research purposes; and Genaissance is willing to grant thislicense upon the terms and conditions set forth below.

 

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

 

# **ARTICLE 1DEFINITIONS**

 

1.1                                 “Affiliate”Affiliate shall mean any corporation or other entity, which directly orindirectly controls, is controlled by or is under common control with a partyto this Agreement.  A corporation orother entity shall be regarded as in control of another corporation or entity ifit owns or directly or indirectly controls more than fifty percent (50%) of theoutstanding voting stock or other ownership interest of the other corporationor entity, or if it possesses, directly or indirectly, the power to manage,direct or cause the direction of the management and policies of the corporationor other entity or the power to elect or appoint fifty percent (50%) or more ofthe members of the governing body of the corporation or other entity.  Any such other relationship as in fact resultsin actual control over the management, business and affairs of a corporation orother entity shall also be deemed to constitute control.

 

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1.2                                 “AuthorizedUsers” shall mean [**].

 

1.3                                 “CandidateGene” shall mean a gene for which WSU requests Genaissance to providegenotyping services pursuant to the Genotyping Contract.

 

1.4                                 “CommercialField of Use” shall mean the discovery, development, manufacture, marketingand selling of diagnostic products and therapeutic products.

 

1.5                                 “*DecoGen®*Informatics System” shall mean software and components thereof and anyassociated documentation, whether existing on the Installation Date ordeveloped by Genaissance during the License Period, which is owned orcontrolled by Genaissance, or licensed (with the right to sublicense) toGenaissance, and which includes the *DecoGen*® Browser software and the *DecoGen®*DataManager software, with the features of these software products beingfurther described in Exhibit A hereto. The *DecoGen*Informatics System shall not include any Third Party software that WSU has independentlyof Genaissance licensed from a Third Party.

 

1.6                                 “GenaissanceKnow-How” shall mean any and all proprietary data, information, know-how,inventions, trade secrets, copyrights, regulatory submissions or otherintellectual property of any kind, other than Genaissance Patent Rights, ownedor controlled by Genaissance as of the effective date or during the term ofthis Agreement including, but without limitation, data on the sequence,frequency and distribution of *HAP* Markers in the HAP  *Focus*TMDatabase.

 

1.7                                 “GenaissancePatent Rights” shall mean Patent Rights that are owned or controlled (withthe 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 byGenaissance that are directed to an association between one or more *HAP*Markers and a specific phenotype, including but not limited to drug response ordisease susceptibility.

 

1.8                                 “Genotype”shall mean an unphased 5’ to 3’ sequence of the two nucleotides found at one ormore Polymorphic Sites on a pair of homologous chromosomes in an individual.

 

1.9                                 “HAP  *FocusTM*Database” shall mean the database that (a) is initiallyinstalled by Genaissance at the WSU site specified in Exhibit B, and allupdates thereof, and (b) contains the following information generated byGenaissance: (i) a gene structure for each of the Candidate Genes, (ii) thePolymorphisms identified in the Index Repository for those Candidate Genes usedin the cohort comparison phase of the Genotyping Contract, (iii) the Genotypes,Haplotypes, and Haplotype Pairs identified in the PRB Patient Population foreach Candidate Gene, and (iv) the frequencies of Genotypes, Haplotypes andHaplotype Pairs in the Index Repository and PRB Patient Population.

 

1.10                           “*HAPTM*Marker Association” shall mean an association that is (a) between aspecific *HAP*Marker or combination of *HAP* Markers and a pregnancy outcomephenotype and (b) discovered solely by employees of WSU or others acting onbehalf of WSU.

 

1.11                           “Haplotype”shall mean any phased 5’ to 3’ sequence of nucleotides present at a set of twoor more Polymorphic Sites for a gene on a single chromosome.

 

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1.12                           “HaplotypePair” shall mean the two Haplotypes found in a single individual for aparticular 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 notpublicly 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 thatcontains at least one Polymorphism that is in the HAP  *Focus* Databaseand 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 orHaplotype that is in the HAP  *Focus* Database, including but not limitedto the frequency and ethnic distribution of Polymorphisms, Haplotypes andHaplotype Pairs in the Index Repository and (b) that is not publicly known atthe time of WSU’s use of such data.

 

1.15                           “IndexRepository” shall mean Genaissance’s proprietary collection of immortalizedcell lines established from unrelated individuals from various geographicalorigins and from members of extended families.

 

1.16                           “InstallationDate” shall mean the date that Genaissance installs, at the WSU sitespecified in Exhibit B, the *DecoGen* Informatics System and the initialversion of the HAP  *Focus* Database, such date to be a datemutually agreed upon by the parties after completion by Genaissance of thesequencing and quality control analysis of the Candidate Genes.

 

1.17                           “PatentRights” shall mean (i) any United States or foreign patent application,(ii) any United States patent or foreign patent issuing from such patentapplication and (iii) any continuation, continuation-in-part (to the extent theclaims in such continuation-in-part application are directed to subject matterspecifically described in such prior patent application), divisional, reissue,re-examination, renewal, substitution, addition, extension, supplementaryprotection certificate or foreign counterpart thereof of any of the foregoing.

 

1.18                           “PolymorphicSite” or “PS” shall mean a specific position within a chromosome at which aPolymorphism is found in a population.

 

1.19                           “Polymorphism”means any alternative nucleotide or contiguous sequence of nucleotides found ata 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 ormore nucleotides; and (d) restriction fragment length polymorphisms.

 

1.20                           “PositiveScientific 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 statisticallysignificant correlation (e.g., p >0.05) between a specific phenotype and oneor more *HAP*Markers in a specific gene for which a prior published report concluded thatthere was a correlation between the same phenotype and a Polymorphism orHaplotype in the same gene.

 

1.21                           “PRBPatient Population” shall mean the WSU/PRB patient samples sent toGenaissance for genotyping and haplotyping analysis pursuant to the GenotypingContract.

 

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1.22                           “ResearchField of Use” shall mean the performance by Authorized Users of researchthat directly relates to use or analysis of Genotypes, Haplotypes and *HAP*Marker Data in the HAP  *Focus* Database solely for purposes ofidentifying correlations between genetic variants and pregnancy outcomes.

 

1.23                           “SNP”means a single nucleotide polymorphism.

 

1.24                           “ThirdParty” means any entity other than Genaissance or WSU.

#  

# **ARTICLE 2INTELLECTUAL PROPERTY**

 

2.1                                 Ownershipof Intellectual Property.

 

2.1.1                        *HAP**Markers*. Genaissance shall own all *HAP* Markers.

 

2.2                                 Licenserights granted to WSU by Genaissance.

 

2.2.1                        *Research License to HAP Markers*.  Subject to the terms of this Agreement, Genaissance shall grantWSU a [**]non-exclusive worldwide license[**] under Genaissance Patent Rightsand Genaissance Know-How to use the *HAP* Markers in the HAP  *Focus* Databasesolely 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[**] underGenaissance 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 theterms of this Agreement, Genaissance shall grant WSU a [**]non-exclusive,non-transferable license, under Genaissance Patent Rights and GenaissanceKnow-How, to use the HAP  *Focus*Database and the *DecoGen*Informatics System, each in machine-readable object code only, at the singlesite specified in Exhibit B solely in the Research Field of Use.  In consideration of this license, WSU shallpay Genaissance [**]dollars ($[**]), which shall be due and payable within[**].

 

2.2.4                        Installation, Training,Support and Updates.  Genaissanceshall install the *DecoGen* Informatics System and the initial version of the HAP  *Focus*Database at the site specified in Exhibit B on the InstallationDate.  The installation and timing ofthe DecoGen**license will be initiatedno more than [**] weeks nor less than [**] prior to the time the first set ofdata will be delivered pursuant to the Genotyping Contract.  Genaissance will provide [**] of on-sitetraining, installation documentation and a user manual at that site.  For a period of [**] after the InstallationDate, Genaissance will also provide (a) technical support via phone and emailto Authorized Users between the hours of 8:30 A.M. and 5:30 P.M. (EasternStandard Time) Mondays through Fridays, except when Genaissance is officiallyclosed (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 Systemon a quarterly basis.  After the end ofsuch [**] period, WSU may elect to obtain, on a consecutive annual basis, theright to receive

 

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technical support and updates to the HAP *Focus* Databaseand *DecoGen*Informatics System at the same frequency provided to other Genaissancecustomers by paying Genaissance the standard commercial price offered byGenaissance for such support and updates at the time of each such annualelection.

 

2.2.5                        For purposes of this subsection2.2.5, 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 besubject to the following conditions:

 

(a)                                  Tothe extent that the Licensed Software incorporates or requires the use of anycommercially available operating system software that is licensed byGenaissance from a Third Party as described in Exhibit A and as notified toWSU, as may be supplemented from time to time, WSU shall be responsible forobtaining any necessary license and paying all fees and charges associated withWSU’s use of any such Third Party software;

 

(b)                                 WSUagrees to use the Licensed Software in accordance with the terms and conditionsof this Agreement and not to use the Licensed Software for processing data forThird Parties or to make Licensed Software available to Third Parties;

 

(c)                                  WSUmay make one (1) copy of the Licensed Software solely for archival or back-uppurposes;

 

(d)                                 WSUagrees to allow only Authorized Users to use or access the Licensed Softwareand further agrees to establish reasonable security measures to prevent copiesof the software product(s) from being made available to Third Parties;

 

(e)                                  Exceptwith the express written permission of Genaissance, WSU agrees that it will notattempt to reverse engineer, reverse compile or otherwise obtain access to thesource code of the Licensed Software; and

 

(f)                                    WSUmay not adapt or modify the Licensed Software without the express writtenpermission of Genaissance.

 

2.2.6                        *Access for Collaborators and Subcontractors*.  The parties agree that WSU may provideaccess to any Genaissance Know-How and/or Genaissance Patent Rights licensed toWSU under this Section 2.2 to collaborators and/or subcontractors of WSU.  Such access shall not be granted until suchcollaborator or subcontractor agrees in writing to be bound by theconfidentiality, nondisclosure and publication provisions of Article 3.  WSU shall promptly provide Genaissance witha copy of the agreement with each such collaborator or subcontractor.

 

2.3                                 NoGrant of Other Technology or Patent Rights.  Except as otherwise expressly provided in this Agreement, underno circumstances shall a party hereto, as a result of this Agreement, obtainany ownership interest in or other right to any technology, know-how, patents,patent applications, data, products, or biological materials of the otherparty, including items owned, controlled or developed by the other party, ortransferred by the other party to said party, at any time pursuant to thisAgreement.

 

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**ARTICLE 3CONFIDENTIALITY AND NONDISCLOSURE**

** **

3.1                                 Forpurposes of this Agreement, the term “Confidential Information” will mean any andall data, know-how, technical and non-technical materials which one party maydeliver or disclose in writing to the other party pursuant to this Agreement,that is marked “Confidential,” and all oral material which one party declaresto be confidential and confirms such declaration in writing within [**] ([**])days of disclosure.  ConfidentialInformation of Genaissance includes but is not limited to *HAP* Markers and *HAP*Marker Data.  Confidential Informationof WSU includes but is not limited to the list of candidate genes and all dataand results generated by Genaissance pursuant to the Genotyping Contract.

 

3.2                                 Confidentialityand Nonuse Obligations.  Except asotherwise provided in this Section 3, during the term of this Agreement and fora period of [**] ([**]) years thereafter, each party agrees to maintain theother party’s Confidential Information in confidence with the same degree ofcare it holds its own confidential information and agrees to use the otherparty’s Information solely for the purposes specifically authorized under thisAgreement.  Notwithstanding theforegoing [**] ([**]) year period, WSU shall not disclose to any Third Partyany *HAP*Marker unless and until such *HAP* Marker [**]becomes public knowledge[**] (b) [**].

 

3.3                                 Exceptionsto Confidentiality.  The receivingparty’s obligation of non-disclosure and the limitations upon the right to usethe disclosing party’s Confidential Information will not apply to the extentthat the receiving party can demonstrate by its written records that theConfidential Information: (a) was in its possession prior to the time ofdisclosure by the disclosing party; (b) is or becomes public knowledge throughno fault or omission of the receiving party; (c) is obtained by the receivingparty from a Third Party under no obligation of confidentiality to thedisclosing party; (d) is required to be disclosed by the receiving partypursuant to an order or demand issued by a court or governmental agency or asotherwise 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 aprotective order or other similar order with respect to such ConfidentialInformation *and provided, further*,that the receiving party furnishes only that portion of the Information whichit is advised by counsel is legally required whether or not a protective orderor other similar order is obtained by the disclosing party; or (e) where thereceiving party reasonably believes such disclosure is reasonably necessary orappropriate to fulfill its obligations or exercise its rights under thisAgreement, with such disclosure being limited to (i) consultants,collaborators, and clinical investigators, on a need-to-know basis and oncondition that such entities or persons agree to keep the ConfidentialInformation confidential for the same time periods and to the same extent assuch party is required to keep the Confidential Information confidential and(ii) government or other regulatory authorities to the extent that suchdisclosure is reasonably necessary to obtain patents or authorizations toconduct clinical trials of, and to commercially market, products.

 

3.4                                 Publication.

#### *** ***

#### ***(a)***                                  General restrictions.  Any partymay publish or present data and/or results generated utilizing the HAP Markersor HAP Focus Database, provided, that in the event

#### *** ***

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that a party desires to publish or present any Confidential Informationof another party, then the proposed disclosure shall be subject to the priorreview by the other party solely to determine (i) whether the proposeddisclosure contains the Confidential Information of the other party or (ii)whether the information contained in the proposed disclosure should be thesubject of a patent application prior to such disclosure.  Each party shall provide the other partywith the opportunity to review any proposed abstract, manuscript or presentationwhich discloses Confidential Information of the other party by delivering acopy thereof to the other party no less than [**] ([**]) days before itsintended submission for publication or presentation.  The other party shall have [**] ([**]) days from its receipt ofany such abstract, manuscript or presentation in which to notify the party inwriting of any specific objections to the disclosure, based on either the needto seek patent protection or concern regarding the specific disclosure of theConfidential Information of such party. In the event a party objects to the disclosure, the other party agreesnot to submit the publication or make the presentation containing theobjected-to information until the party is given a reasonable additional periodof time (not to exceed an additional [**] ([**]) days) to seek patentprotection for any material in the disclosure which it believes is patentableor, in the case of Confidential Information, to allow the publishing party todelete any Confidential Information of the other party from the proposeddisclosure.  Each party agrees to deletefrom the proposed disclosure any Confidential Information of the other partyupon request.  *For the avoidance of doubt*, this sectionshall not place any restrictions on the freedom of WSU (or collaborators andsubcontractors authorized under section 2.2.6) to publish anything related toany Polymorphism or Haplotype that is publicly known or discovered by WSU (orcollaborators and subcontractors authorized under section 2.2.6) independentlyof use of the HAP  *Focus* Database or the *DecoGen* Informatics System.

 

#### ***(b)***                                 Exceptions to GeneralRestrictions. Notwithstanding subsection (a) of this Section 3.4, Genaissance shallnot require WSU or collaborators and subcontractors authorized under section2.2.6 to remove HAP Markers and related HAP Marker Data from any proposeddisclosure if (a) [**](b) [**] or (c) the HAP Markers or related HAP MarkerData have become publicly known prior to the proposed disclosure.  In addition, Genaissance shall not requireWSU or collaborators and subcontractors authorized under section 2.2.6 toremove from any proposed disclosure the number and population frequency of HAPMarkers in the HAP Focus Database that were analyzed in generating the resultsdescribed in such disclosure.

 

**ARTICLE 4REPRESENTATIONS AND WARRANTIES**

 

4.1                                 Representations,Warranties and Covenants of Genaissance. Genaissance represents and warrants to and covenants with WSU that:

 

(a)                                  Genaissancehas the legal right, authority and power to enter into this Agreement, and to extendthe rights and licenses granted to WSU in this Agreement;

 

(b)                                 Genaissancehas taken all necessary action to authorize the execution, delivery andperformance of this Agreement;

 

(c)                                  uponthe execution and delivery of this Agreement, this Agreement shall constitute avalid and binding obligation of Genaissance enforceable in accordance with its

 

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terms, except as enforceability may be limited by applicablebankruptcy, insolvency, reorganization, moratorium or similar laws affectingcreditors’ and contracting parties’ rights generally and except asenforceability may be subject to general principles of equity (regardless ofwhether such enforceability is considered in a proceeding in equity or at law);

 

(d)                                 theperformance of its obligations under this Agreement will not conflict with itscharter documents or result in a breach of any agreements, contracts or otherarrangements to which it is a party; and

 

(e)                                  Genaissancewill not after the Effective Date enter into any agreements, contracts or otherarrangements that would be inconsistent with its obligations under thisAgreement.

 

4.2                                 Representations,Warranties and Covenants of WSU. WSU represents and warrants to and covenant with Genaissance that:

 

(a)                                  WSUhas the legal right, authority and power to enter into this Agreement;

 

(b)                                 WSUhas taken all necessary action to authorize the execution, delivery andperformance of this Agreement;

 

(c)                                  uponthe execution and delivery of this Agreement, this Agreement shall constitute avalid 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 contractingparties’ rights generally and except as enforceability may be subject togeneral principles of equity (regardless of whether such enforceability isconsidered in a proceeding in equity or at law);

 

(d)                                 theperformance of its obligations under this Agreement will not conflict withWSU’s charter documents or result in a breach of any agreements, contracts orother arrangements to which it is a party; and

 

(e)                                  WSUwill not after the Effective Date enter into any agreements, contracts or otherarrangements that would be inconsistent with its obligations under thisAgreement.

 

4.3                                 WarrantyDisclaimer.  EXCEPT AS OTHERWISEEXPRESSLY PROVIDED IN THIS AGREEMENT, GENAISSANCE DOES NOT MAKE ANY WARRANTYWITH RESPECT TO THE *HAP* MARKERS, PATENT RIGHTS, GOODS, SERVICESOR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OFMERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITHRESPECT 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 ORWARRANTIES WITH RESPECT TO WSU’S USE OF THE INFORMATION TO BE PROVIDED TO ITHEREUNDER.

 

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4.4                                 LimitedLiability.  NOTWITHSTANDING ANYTHINGELSE IN THIS AGREEMENT OR OTHERWISE TO THE CONTRARY, THE PARTIES SHALL NOT BELIABLE TO EACH OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDERANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORYFOR (I) ANY PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSTPROFITS OR (II) COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY ORSERVICES.

 

**ARTICLE 5EXPIRATION AND TERMINATION**

 

5.1                                 Termof Agreement.  Unless this Agreementis 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 theGenotyping Contract for any reason other than breach of Genaissance inperforming its obligations thereunder.

 

5.2                                 Eventsof Default.  An Event of Defaultshall have occurred upon the occurrence of a material breach of this Agreementif the breaching party fails to remedy such breach within [**] ([**]) daysafter written notice thereof by the non-breaching party.

 

5.3                                 Effectof an Event of Default.

 

5.3.1                        Remedies Available toGenaissance.  In the event that anEvent of Default occurs relating to WSU and WSU fails to cure such defaultduring any applicable cure period, Genaissance shall have the right, at itsoption exercisable in its sole discretion, in addition to any other rights orremedies available to it at law or in equity, to terminate WSU’s rights underthis Agreement upon notice thereof to WSU, in which case (i) the licenses andoption granted to WSU pursuant to Article 2 shall terminate and (ii) WSU shalldestroy all copies of the HAP *Focus* Database and *DecoGen*Informatics Platform that are in its possession and shall provide Genaissancewith written notice of the completion of such destruction.

 

5.3.2                        Remedies Available to WSU.  In the event that an Event of Default occursrelating to Genaissance and Genaissance fails to cure such default within theapplicable cure period, then WSU shall have the right, at its optionexercisable in its sole discretion, to seek any rights or remedies available toit at law or in equity, subject to the limitations set forth in Section 4.4hereof or any applicable provisions of the Genotyping Contract.

 

5.4                                 Effectof Expiration or Termination of Agreement. The expiration or termination of this Agreement shall not relieve theparties of any obligation accruing prior to such expiration ortermination.  The provisions of Sections2.1, 2.2, 2.3, and of Articles 3 and 4 hereof shall survive the expiration ortermination of this Agreement.

** **

**ARTICLE 6MISCELLANEOU**S

 

6.1                                 DisputeResolution.  The parties herebyagree that they will attempt in good faith to resolve any controversy or claimarising out of or relating to this Agreement promptly by

 

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negotiations.  If a controversyor claim should arise hereunder, the matter shall be referred to an individualdesignated by the Chief Executive Officer (or the equivalent position) ofGenaissance and an individual designated by the President (or the equivalentposition) of WSU (the “Representatives”). If the matter has not been resolved within [**] ([**]) days of the firstmeeting of the Representatives of the parties (which period may be extended bymutual agreement) concerning such matter, each party may pursue available legalor equitable remedies.

 

6.2                                 ForceMajeure.  Neither party shall beheld liable or responsible to the other party nor be deemed to have defaultedunder or breached this Agreement for failure or delay in fulfilling orperforming any term of this Agreement when such failure or delay is caused byor results from causes beyond the reasonable control of the affected party,including but not limited to fire, floods, embargoes, war, acts of war (whetherwar is declared or not), insurrections, riots, civil commotions, strikes,lockouts or other labor disturbances, acts of God or acts, omissions or delaysin acting by any governmental authority or the other party; *provided, however*, that the party soaffected shall use reasonable commercial efforts to avoid or remove such causesof nonperformance, and shall continue performance hereunder with reasonabledispatch whenever such causes are removed. Either party shall provide the other party with prompt written notice ofany delay or failure to perform that occurs by reason of *force majeure*.  The parties shall mutually seek a resolution of the delay or thefailure to perform as noted above.

 

6.3                                 Assignment.  This Agreement may not be assigned orotherwise transferred by either party without the prior written consent of theother 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 orsale of substantially all of its assets to an unrelated Third Party; *provided, however*, that Genaissance’srights and obligations under this Agreement shall be assumed by its successorin interest in any such transaction and shall not be transferred separate fromall or substantially all of its other business assets, including those businessassets that are the subject of this Agreement. Any purported assignment in violation of the preceding sentence shall bevoid.  Any permitted assignee shallassume all obligations of its assignor under this Agreement.

 

6.4                                 Severability.  Each party hereby agrees that it does notintend to violate any public policy, statutory or common laws, rules,regulations, treaty or decision of any government agency or executive bodythereof of any country or community or association of countries.  Should one or more provisions of thisAgreement be or become invalid, the parties hereto shall substitute, by mutualconsent, valid provisions for such invalid provisions which valid provisions intheir economic effect are sufficiently similar to the invalid provisions thatit can be reasonably assumed that the parties would have entered into thisAgreement with such valid provisions. In case such valid provisions cannot be agreed upon, the invalidity ofone or several provisions of this Agreement shall not affect the validity ofthis Agreement as a whole, unless the invalid provisions are of such essentialimportance to this Agreement that it is to be reasonably assumed that theparties would not have entered into this Agreement without the invalidprovisions.

 

6.5                                 Notices.  Any consent, notice or report required orpermitted to be given or made under this Agreement by one of the parties heretoto the other shall be in writing, delivered personally or by facsimile (andpromptly confirmed by telephone, personal delivery or courier)

 

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or courier, postage prepaid (where applicable), addressed to such otherparty at its address indicated below, or to such other address as the addresseeshall have last furnished in writing to the addressor and shall be effectiveupon receipt by the addressee.

 

6.6                                 Ifto Genaissance:                                                 GenaissancePharmaceuticals, Inc. 
| Five Science Park                  |
|------------------------------------|
| New Haven, Connecticut 06511       |
| Attention: Chief Executive Officer |
| Telephone: (203) 773-1450          |
| Facsimile: (203) 562-9377          |

 

If to WSU:                                                                                     JoanGossman 
| Director of  Purchasing |
|-------------------------|
| 5700 Cass Avenue        |
| Suite 4200              |
| Detroit, MI  48202      |

 

6.7                                 ApplicableLaw.  This Agreement shall begoverned 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                                 EntireAgreement.  This Agreement, togetherwith any exhibits hereto, contains the entire understanding of the parties withrespect to the subject matter hereof. All express or implied agreements and understandings, either oral orwritten, heretofore made are expressly merged in and made a part of thisAgreement.  This Agreement may beamended, or any term hereof modified, only by a written instrument dulyexecuted by both parties hereto.

 

6.9                                 Publicity.  Except as required by law, Genaissance andWSU each agree not to disclose the terms or conditions of this Agreement to anyThird Party without the prior written consent of the other party, which shallnot be withheld unreasonably.  Use ofeach other’s names requires prior consent.

 

6.10                           Headings.  The captions to the several Articles andSections hereof are not a part of this Agreement, but are merely guides orlabels to assist in locating and reading the several Articles and Sectionshereof

 

6.11                           NoPartnership.  It is expressly agreedthat the relationship between Genaissance and WSU shall not constitute apartnership, 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 shallbe binding on any other party, without the prior consent of such party to doso.

 

6.12                           Waiver.  The waiver by a party hereto of any righthereunder or the failure to perform or of a breach by one of the other partiesshall not be deemed a waiver of any other right hereunder or of any otherbreach or failure by said other party whether of a similar nature or otherwise.

 

6.13                           Counterparts.  This Agreement may be executed in twocounterparts, each of

 

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which shall be deemed an original, but all of which together shallconstitute one and the same instrument.

** **

**[Remainder of page intentionally leftblank.]**

 

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IN WITNESS WHEREOF, the parties have caused their dulyauthorized officer to execute and deliver this Agreement as of the date firstset 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**

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** **

**ExhibitA**

** **

**DeploymentSpecifications for *DecoGen* Informatics System**

** **

##### ***1.*****                                     ****Database Configuration**

•                                          Software:Oracle[**] Edition, typical install, and [**] applied.

 

HardwareRequirements: For [**]

 

•                                          Memory:[**]GB, depending on number of users. Genaissance has [**]GB to support [**] instances and around [**] users.

 

•                                          SWAP Space:[**].

 

•                                          CD-ROMDevice: [**]s.

 

•                                          CPU: [**]

 

Disk SpaceRequirements:

 

•                                          OracleSoftware: around [**]GB ([**]Edition)

 

•                                          Database:for the data volume of [**], the database size would be [**]GB.  For best database performance, we would[**].

 

Operating SystemSoftware Requirements

 

•                                          OperatingSystem: [**]

 

•                                          [**]

##### *** ***

##### ***2.*****                                     ****Application (File) Server Configuration:**

 

•                                          [**]

##### *** ***

##### ***3.*****                                     ****SAS Server Configuration:**

 

Detailed SASserver requirements:

 

•                                          SAS Version:SAS Software 8.2 release on NT or Windows 2000 server.

 

•                                          SASSoftware 8.2 required components/modules must include SAS/BASE, SAS/STAT,SAS/CONNECT, SAS/IntraNet.

##### *** ***

**4.****                                      End-UserClient Computer Configuration:**

 

The standard computer configuration we recommend is:

 

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•                                          CPU: [**];

 

•                                          Memory: [**];

 

•                                          Hard disk:[**];

 

•                                          OperatingSystem: Window [**]

 

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**ExhibitB**

** **

**InstallationSite for DecoGen InformaticsSystem and HAP  *Focus*Database**

 

Wayne State University

[**]Detroit, MI 48201

 

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**[Attachment8]**

** **

**ADDENDUM3 TO PROPOSAL, ADDITIONAL SERVICES**

** **

I.              Comparison ofCohorts

 

A.            *Description of Service*.  The objective of this service is to confirmthat 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 [**]DNAfragments from gene regions in [**] unrelated [**] individuals from the patientcohort that is to be studied in the genotyping project.  These [**] fragments will be chosen fromautosomal genes on the list of candidate genes.  The criteria for selecting the [**] DNA fragments will be thefollowing.  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, suchas the patients in the Company’s STRENGTH clinical trial with the individualsin the Company’s IR.  The results ofsuch 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 fromthe IR, 991 (96%) were also observed in the 590 Caucasians in the STRENGTHcohort.

 

The [**] fragments to be sequenced should besufficient to demonstrate that the SNPs discovered by Genaissance in its IR canbe used to capture the haplotype diversity that is present in the[**]cohort.  Genaissance does expectthat the sequencing of these [**]fragments will identify some novel SNPs thatare present in the [**] cohort. However, the Company does not expect that a significant number will bepresent in the [**] cohort at a high frequency.  In addition, the [**]autosomal DNA fragments, which should yieldat least [**]SNPs genotyped on [**]individuals, will provide sufficientinformation to establish a protocol to select SNPs for the genotyping project.  That is, [**], should be the criterion usedfor determining whether to genotype that SNP in the [**] cohort.

 

B.            *Service Fee*.  [**]

 

II.            SequenceFinishing and Quality Control Analysis of Candidate Genes

 

A.            *Description of Service*.  The objective of this service is to ensurethat all candidate genes (approximately 200) in the *HAP*Database have an up to date genomic structure and thatthe sequencing analysis of these genes meets Genaissance’s standards, asdefined in Attachment A to this Addendum 3. [**]Genaissance will check the genomic structure recorded in the *HAP*Database for each of the candidategenes against the latest publicly available information and make any necessaryadjustments to the genomic structures in the HAP Database.  Genaissance will then sequence thosefragments that are necessary to bring the genes up to the standards set forthin Attachment A.

 

C.            *Service Fee*.  [**]

** **

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**AttachmentA**

** **

**GeneSequencing Standards**

 

The current procedure for discovering *HAP*Markers for a gene is to sequence,from the Index Repository, ninety-three (93) individual samples of humangenomic DNA, one sample of chimpanzee genomic DNA and one sample of gorillagenomic DNA.  The genomic regions ofeach gene, which are targeted for sequencing, are as follows.

 

(i)            “Exons”shall mean the genomic DNA segments of a gene whose sequence information istranslated into the protein product of that gene.  The goal is to obtain sequence information for all Exons of agene.

 

(ii)           “Exon/IntronJunction” shall mean the junctions between the Exons and the Introns in genomicDNA.  Beginning with the initiationcodon at one end of a gene and ending with the termination codon at the otherend of a gene, the goal is to obtain sequence information for each Exon/IntronJunction within this genomic region.

 

(iii)          “Introns”shall mean the genomic DNA segments of a gene, which are located betweenExons.  Beginning with the initiationcodon at one end of a gene and ending with the termination codon at the otherend of a gene, the goal is to obtain a minimum of ten (10) to twenty (20) basesand a maximum of one hundred (100) bases of sequence information from theExon/Intron Junction into the Intron for every Intron within this genomicregion.

 

(iv)          “Promoter”shall mean the genomic region that is immediately upstream of the transcriptionstart site of the gene.  The goal is toobtain sequence information for up to one (1) thousand bases of the Promoter.

 

(v)           “Three-PrimeUntranslated Region” shall mean the genomic region immediately downstream fromthe termination codon of a gene.  Thegoal is to obtain sequence information for at least one hundred (100) bases ofthe Three-Prime Untranslated Region downstream of the termination codon.

 

Specific genomic sequence information is required tomeet the goals outlined in (i) through (v) above.  If genomic sequence information is available for a majority ofthese regions, even if the available genomic sequence information is notsufficient to meet all of the goals in (i) through (v) above, a gene will stillbe queued for *HAP*Markerdiscovery.

 

Once a gene is completely sequenced, *HAP*Markers will be constructed for thatgene and placed into the *HAP*Database.  A gene shall be considered completelysequenced if sequence information is obtained for at least [**] ([**]) of theregions targeted for sequencing.  Aspecific region targeted for sequencing within a gene shall be consideredcompletely sequenced if sequence information is obtained for at least [**].

 

If a gene is not completely sequenced after eachfragment targeted for sequencing has been attempted once, each of the failedfragments will be resequenced using redesigned

 

2

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amplification/sequencing primers. However, the presence of runs of guanine and cytosine, secondarystructure or errors in publicly available sequence information may prevent thegeneration of sufficient sequence information for that gene to be consideredcompletely sequenced.  Thus, if the genedoes not meet the completely sequenced criteria after the above resequencingstep, *HAP*Markers will beconstructed for that gene and placed into the *HAP*Database.

 

3

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**[Attachment9]**

** **

**WSUPROJECT SEQ TRACKING**

Confidential and Proprietary, GPI

 
| **1**  |   | **2**  |   | **3**  |   | **4**  |   | **5**  |   | **6**  |   | **7**  |   | **8**            |   | **9**  |   | **10** |   | **11** |   | **12** |   | **13** |   | **14** |   | **15**          |   | **16** |   | **17**          |   | **18** |   | **19** |   | **20**          |   | **21** |   | **22** |   | **23** |   | **24** |
|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|------------------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|-----------------|--------|--------|--------|-----------------|--------|--------|--------|--------|--------|-----------------|--------|--------|--------|--------|--------|--------|--------|--------|
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
| **1**  |   | **2**  |   | **3**  |   | **4**  |   | **1**  |   | **2**  |   | **3**  |   | **4**            |   | **5**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |   | **5**  |   | **1**           |   | **2**  |   | **3**           |   | **4**  |   | **1**  |   | **2**           |   | **3**  |   | **4**  |   | **1**  |   | **2**  |
| [**]   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
| [**]   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
| [**]   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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|   |   | [**]   |   |   |   |   |   |   |   | [**]   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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|   |   |   |   |   |   |   |   |   |   | [**]   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   | [**]             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   | [**] genes done |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   | [**]   |   |   |   |            |   |   |   | [**] genes done |   |   |   |   |   |            |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   | [**]   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
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| [**]   |   |   |   |   |   |   |   |   |   |   |   |   |   | [**]  genes |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   | [**] genes done |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   |            |   |   |   |            |   |   |   |   |   |            |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |             |   |   |   |   |   |   |   |   |   |   |   |   |   | [**] genes      |   |   |   |            |   |   |   |   |   | [**] genes      |   |   |

 

4

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| **25** |   | **26** |   | **27** |   | **28** |   | **29** |   | **30** |   | **31** |   | **32** |   | **33** |   | **34** |   | **35** |   | **36** |   | **37** |   | **38** |   | **39** |   | **40** |   | **41** |   | **42** |   | **43** |   | **44** |   | **45** |   | **46** |   | **47** |
|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
| **3**  |   | **4**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |   | **5**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |   | **1**  |   | **2**  |   | **3**  |   | **4**  |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
|   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |

----

| Project Assumptions: | 1. |   | [**] |
|----------------------|----|--------|------|
|                 | 2. |   | [**] |
|                 | 3. |   | [**] |
|                 | 4. |   | [**] |
|                 | 5. |   | [**] |
|                 | 6. |   | [**] |

 

5

----

 

**[Attachment 10]**

 

**WSUPROJECT TRACKING**

 

GENAISSANCE PHARMACEUTICALS, INC.                          Confidentialand Proprietary

 
| **1**  |   | **2**  |   | **3**  |   | **4**  |   | **5**  |   | **6**  |   | **7**  |   | **8**  |   | **9**  |   | **10** |   | **11** |   | **12** |   | **13** |   | **14** |   | **15** |   | **16** |   | **17** |   | **18** |   | **19** |   | **20** |   | **21** |   | **22** |   | **23** |   | **24** |   | **25** |   | **26** |   | **27** |   | **28** |   |
|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|--------|
| [**]   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |   |
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| Project Assumptions: | 1. |   | [**] |
|----------------------|----|--------|------|
|                 | 2. |   | [**] |
|                 | 3. |   | [**] |
|                 | 4. |   | [**] |
|                 | 5. |   | [**] |

 

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**[Attachment11]**

 

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**

 

**GenaissancePharmaceuticals Signs Agreement with Wayne State University toSupport 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 StateUniversity (WSU) to support WSU’s research contract with the National Instituteof 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 tospecific *HAP*TM Markers and obtaina limited license to use the Company’s *DecoGen®*Informatics System.  Genaissance willdevelop assays for the selected *HAP*TMMarkers and provide high-throughput genotyping on clinical samples provided byWSU and the PRB.  Genaissance willreceive a license fee and other payments from WSU.

 

“We are delighted to enter into an agreement with WSU, which is workingwith the PRB to address important healthcare issues of adverse pregnancyoutcomes,” said Gerald F. Vovis, Ph.D., Executive Vice President and ChiefTechnology Officer of Genaissance Pharmaceuticals.  “This is our first major agreement in the public sector andreinforces the utility of our *HAP*TMTechnology for helping to detect associations between clinical outcomes andgenetic variation.”

* *

*About Genaissance:*

Genaissance Pharmaceuticals, Inc is a world leader in the discovery anduse of human gene variation for the development of personalized medicines.  The Company markets its technology andclinical development skills to the pharmaceutical industry as a completesolution for improving the development, marketing and prescribing of drugs.  Genaissance has agreements with eight majorpharmaceutical, diagnostic and biotechnology companies:  AstraZeneca, Bayer, BD (Becton, Dickinsonand Company), Biogen, Johnson & Johnson PRD, Millennium, Pfizer andPharmacia.  Genaissance is located inScience Park in New Haven, Connecticut.

 

*About Wayne State University:*

With more than 1,000 medical students, WSU is among the nation’slargest medical schools.  Together withits clinical partner the Detroit Medical Center, the school is a leader inpatient care and medical research in a number of areas, including cancer,genetics, the neurosciences and women’s and children’s health.

 

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*This press release containsforward-looking statements, including statements about the ability ofGenaissance to apply its technologies to the development, marketing andprescribing of drugs and to detect associations between clinical outcomes andgenetic variation.  Such statements aresubject to certain factors, risks and uncertainties that may cause actualresults, events and performance to differ materially from those referred to insuch statements, including, but not limited to, the extent to which geneticmarkers (haplotypes) are predictive of clinical outcomes and drug efficacy andsafety, the attraction of new business and strategic partners, the adoption ofour technologies by the pharmaceutical industry, the timing and success ofclinical trials, competition from pharmaceutical, biotechnology and diagnosticscompanies, the strength of our intellectual property rights and those risksidentified in our Annual Report on Form 10-K filed with the Securities andExchange Commission on March  7, 2002 and our Quarterly Reports onForm 10-Q for the quarter ended March 31, 2002, June 30, 2002and September 30, 2002 as filed with the Securities and Exchange Commissionon May 14, 2002, August 14, 2002 and November 14, 2002,respectively.  The forward-lookingstatements contained herein represent the judgment of Genaissance as of thedate of this release.  Genaissancedisclaims any obligation to update any forward-looking statement.*

 

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