investigator agreement template - University of Pennsylvania

INVESTIGATOR AGREEMENT TEMPLATEJuly 25, 2002«InvestigatorName»«Institution»«Address1»«Address2»«City», «State» «ZipCode»Dear Dr. «LastNameInvest»:Enclosed please find two (2) originals of our standard Statement of Agreement (Contract) for your studyNUMBER«InvestigatorNumber»; STUDY DESCRIPTIONPlease have both contracts signed by the appropriate personnel at «Institution» and return themto me as soon as possible. Do not return them to the clinician. A Federal Express envelope andshipping label are enclosed for your convenience.If you have any questions regarding Attachment A, payment or invoices, please contact Esther Gowitzkein the grants department at (860) 441-3989. Any questions that you or your institution may haveregarding clauses in this contract should be directed to me. Please do not contact the clinician directly forcontractual or payment questions/negotiations.It is important to note that if a signed contract is not received within a reasonable amount of time,disbursal of the first payment could be delayed.A fully executed contract will be in effect once the study is filed to the IND or drug is shipped. Firstpayment will be processed upon drug shipment.A copy of the protocol, as filed to our regulatory group, will be sent to you under separate cover.Thank you. Should you have any questions or problems, please call me directly at (860) 715-1425 or youcan reach me by fax at (860) 715-2686.Sincerely,George E. SawickiContracts AdministratorGES/llmEnclosurescc: Contract FileVersion 1 – 3/12/01

PFIZER INCSTATEMENT OF AGREEMENTFor the purposes of this Agreement the following will be parties of record:The Trustees of the University of Pennsylvania as INSTITUTIONPfizer Inc and Affiliates as SPONSORWhereas, the research program contemplated by this Agreement is of mutual interest and benefit to theInstitution and to the SPONSOR and will further the Institution’s instructional and researchobjectives in a manner consistent with its status as a non-profit, tax-exempt, educationalinstitution.1. INSTITUTION and SPONSOR agree to conduct a clinical Study titled: STUDY DESCRIPTION,NUMBER-«InvestigatorNumber», according to the Protocol, which has been approved byINSTITUTION, its Institutional Review Board and Pfizer Global Research and Development, adivision of SPONSOR. In this undertaking the INSTITUTION agrees to devote its best efforts inorder to efficiently perform the work required under this Agreement. Principal Investigator will beresponsible for the direction of the Research in accordance with applicable Institution policies,generally accepted standards of good clinical practice, all applicable local, state and federal lawsand regulations governing the performance of clinical investigations.2. The approved reimbursement rate for the Study to be conducted by the INSTITUTION is includedin “Attachment A”.3. Any alteration in or amendment to the Protocol or any additional clause in this Agreement mustbe approved in writing by the INSTITUTION, its Institutional Review Board and SPONSOR priorto such alteration or amendment becoming effective.However, this provision shall not preclude immediate modification in the patient inclusion criteriaor management deemed clinically appropriate by the INSTITUTION and SPONSOR providedsuch modification is subsequently documented in writing signed by the INSTITUTION andSPONSOR.4. The Study may be terminated by written notice from SPONSOR to the INSTITUTION for any ofthe following reasons:ANotification to SPONSOR from Federal or State Regulatory Authorities to terminate saidStudy.B. Determination by SPONSOR that the INSTITUTION is not performing the Study asrequired in the Protocol and/or is not meeting the agreed upon enrollment.C. Failure of the INSTITUTION to provide access by SPONSOR representatives to any andall original medical records necessary to verify entries on Study case report forms.D. Failure of the INSTITUTION, associated staff or any other person engaged in the Study(excluding patients) to be available, upon reasonable notice by SPONSOR, to meet withSPONSOR monitors during the course of the Study as necessary to discuss informationrelevant to the Study.E. Failure of the INSTITUTION to comply with all regulatory requirements as delineated inForm FDA-1572 signed by the PRINCIPAL INVESTIGATOR.Version 1 – 3/12/01

F. Unauthorized replacement of the PRINCIPAL INVESTIGATOR.G. Determination by SPONSOR that business or scientific considerations requiretermination.H. Case report forms provided to the INSTITUTION by SPONSOR for use in this Study arenot legibly completed and forwarded to Pfizer Inc or its designated representative, asappropriate, within two (2) weeks of each patient's visit date.I. If the emergence of any adverse reaction or side effect with the Study drug in the Studyor elsewhere is of such magnitude or incidence to support termination.J. The study may be terminated by the Institution if it believes such termination is necessaryto protect the best interests of the study subjects or for a breach by sponsor of any of itsmaterial obligations under such study, which breach is not cured within thirty daysfollowing receipt of written notice thereof from Institution.5. In the event that either party wishes to exercise its right to terminate this Study based on any ofthe enumerated grounds above, written notice of its decision to exercise such right shall be givenby registered mail delivered fifteen (15) days before said termination.6. Immediately upon receipt of a notice of termination, the INSTITUTION shall stop entering patientsinto the Study and shall cease conducting procedures, to the extent medically permissible, onpatients already entered into the investigational Protocol.7. In the event of termination, the sum payable under this Agreement shall be limited to proratedfees based on actual work performed pursuant to the Protocol. Any unexpended funds not duepayee under this calculation but already paid to payee per Attachment A shall be returned toSPONSOR.8. Notwithstanding any of the above, if during the life of this Agreement Study Drug is approved bythe Food & Drug Administration or information becomes available to SPONSOR which places thesafety or efficacy of the product in doubt, the parties agree to negotiate in good faith with anobjective being the modification of this contract to reduce the number of patients to be studiedand/or similarly modify any other relevant requirement.9. Payments are dependent upon the data as described in the Protocol being submitted toSPONSOR representatives in a timely and satisfactory manner on the case report form provided.Any patient maintained in this trial who is found to be a deliberate Protocol violator shall becompensated for at 50% of the individual visit costs.The final payment will be adjusted to reflect the data collected on the actual number of qualifiedpatients entered, number of patients screened, and the work completed on those patients asdetermined by review of the case reports received against the Protocol requirements.This final payment will only be made after an accounting of all experimental Drug has been madeusing SPONSOR procedures.10. SPONSOR shall retain ownership of all original case reports, which result from this Study.However, the INSTITUTION shall have publication privileges provided such manuscript issubmitted to SPONSOR for review prior to submission for publication. No right of manuscriptapproval by SPONSOR is implied by this provision; however, SPONSOR does request that, if inSPONSOR's judgment publication at a given time would help or hinder SPONSOR'sdevelopment of DRUG NUMBER INSTITUTION would consider, without obligation, modificationof the publication schedule accordingly. Should the INSTITUTION decide not to publish, whichVersion 1 – 3/12/01

granted if it is deemed to be commercially reasonable under the circumstances of theinvention. For New Inventions or Discoveries, which are not related to an indication, useor dosage for the study drug or device, Institution grants Sponsor a first option tonegotiate to acquire a royalty-bearing license to practice such New Inventions orDiscoveries. Institution and Sponsor will negotiate in good faith to determine the terms ofa license agreement as to each New Invention or Discovery for which Sponsor hasagreed to make payment for intellectual property expenses as provided for in ParagraphC above. If Sponsor and Institution fail to execute a license agreement within six (6)months after disclosure of the New Inventions or Discovery to Sponsor or if Sponsor failsto make payment for intellectual property expenses as provided for in Paragraph C,Institution shall be free to license the New Invention or Discovery to any party upon suchterms as Institution deems appropriate, without any further obligation to Sponsorprovided however, that nothing in this agreement shall license or otherwise convey anyright of any kind to INSTITUTION in any patent claiming the subject matter of this study.E. It is agreed that neither the Sponsor nor the Institution transfers to the other party byoperation of this Agreement any patent right, copyright right, or other proprietary right ofeither party, except as specifically set forth herein.14. SPONSOR undertakes to indemnify, defend, and hold harmless the INSTITUTION, its trustees,officers, agents and employees from any and all liability, loss or damage they may suffer as theresult of claims, demands, costs or judgments against them arising out of the activities to becarried out pursuant to the clinical research Protocol designated as STUDY DESCRIPTION;Study DRUG NUMBER«InvestigatorNumber»; provided, however, that any such liability, loss, ordamage resulting from:(i)(ii)(iii)a failure to adhere to the terms of the Protocol or SPONSOR's written instructionsrelative to use of the investigational Drug,failure to comply with any applicable FDA or other governmental requirements, ornegligence or willful malfeasance by the INSTITUTION, its trustees, officers, agents andemployeesis excluded from this Agreement to indemnify and hold harmless.The INSTITUTION agrees to notify SPONSOR as soon as it becomes aware of a claim or actionand to cooperate with and to authorize SPONSOR to carry out the sole management anddefense of such claim or action. SPONSOR agrees, at its own expense, to provide attorneys todefend against any actions brought or filed against the INSTITUTION, its trustees, officers,agents and employees with respect to the subject of indemnity contained herein, whether suchclaims or actions are rightfully brought or filed.Neither the INSTITUTION nor its trustees, officers, agents or employees shall compromise orsettle any claim or action without the prior written approval of SPONSOR. Neither party heretomay assign, cede or transfer any of its rights or obligations under this Agreement without thewritten consent of the other party, which consent may not be unreasonably withheld; provided,however, without such consent either party may assign this Agreement in connection with thetransfer or sale of all or substantially all of its assets or business or its merger or consolidationwith another company. Either party may assign this Agreement in whole or in part to anycorporate affiliate without consent of the other party. This Agreement shall inure to the benefit ofand be binding upon each party signatory hereto, its successors and permitted assigns. Noassignment shall relieve either party of the performance of any accrued obligation which suchparty may then have under this Agreement.Version 1 – 3/12/01

15. The parties will maintain during the performance of this Agreement a policy of policies ofcomprehensive general liability insurance including broad form and contractual liability andproduct liability, in a minimum amount of $3,000,000 combined single limit per occurrence and inthe aggregate with respect to personal injury, bodily injury and property damage. Such insuranceshall be issued by an insurance carrier with an A.M. Best rating of “A” or better. Sponsor willprovide Institution with a certificate of insurance evidencing such coverage upon signing of thisAgreement. Such certificate to be forwarded to:Executive DirectorResearch ServicesUniversity of Pennsylvania133 South 36 th Street, MezzaninePhiladelphia, PA 19104-3246Sponsor shall provide Institution with thirty- (30) day’s advance written notice of cancellation or ofmaterial change in the policy or policies of insurance required. A copy of the insurance certificatewill be provided upon renewal.16. In undertaking to perform professional services for SPONSOR, it is understood that theINSTITUTION is doing so as an independent contractor and not as an employee of SPONSOR.As an independent contractor, the INSTITUTION’s fees will be limited to those stated above.Neither the INSTITUTION nor any associated staff performing the agreed-to investigation willparticipate in any SPONSOR employee benefit plans nor receive any other compensationbeyond that stated above.17. It is understood that payments to payee, as defined in Attachment 1, for services rendered underthis Agreement shall be made in full at the agreed rate without any deductions for taxes of anykind whatsoever, this being in conformity with non-employee status. It is understood that anytaxes that may be due and payable as a result of the payments herein specified by SPONSOR topayee, as defined in Attachment 1, shall be entirely the recipient's responsibility. It is understoodthat, as part of this Agreement, the recipient undertakes to pay all taxes on such payments forwhich it may be liable when due.18. Upon completion or termination of the Study, the INSTITUTION agrees to provide writtenacknowledgment that all work requested under this Agreement has been completed and allmonies due have been received.19. (a) INSTITUTION represents that it has never been, and its employees and investigatorswho will be rendering services to SPONSOR have never been, (i) debarred or convictedof a crime for which a person can be debarred under 21 U.S.C. § 335a (§"335a") nor (ii)threatened to be debarred or indicted for a crime or otherwise engaged in conduct forwhich a person can be debarred under § 335a.(b)(c)(d)INSTITUTION agrees that it will promptly notify SPONSOR in the event of any suchdebarment, conviction, threat or indictment occurring during the term of this Agreement,or the three (3) year period following the termination or expiration of this Agreement.During the term of this Agreement, INSTITUTION agrees not to employ or otherwiseengage any individual who will be rendering services to SPONSOR who has been (i)debarred or (ii) convicted of a crime for which a person can be debarred.Upon SPONSOR's request from time to time, INSTITUTION will certify to SPONSOR inwriting INSTITUTION's compliance with the foregoing provisions of this paragraph.20. Notice:If to Institution:If to SponsorVersion 1 – 3/12/01

For Technical MattersPfizer IncEastern Point RoadPrincipal Investigator Groton CT 06340Attn. Bruce LinkovFax: 860 441 8288Phone: 860 441 5223cc: Assistant General CounselFor Administrative MattersExecutive DirectorOffice of Research ServicesUniversity of Pennsylvania133 South 36 th Street, MezzaninePhiladelphia, PA 19104-324621. The sponsor shall reimburse for medical expenses incurred by research subjects as a result ofparticipation in the study.If the foregoing terms are acceptable to you, please so indicate by signing and returning the enclosedcopy of this Agreement.THIS CONTRACT DOES NOT BECOME EFFECTIVE UNTIL THIS STUDY HAS BEEN FILED TO OURIND, OR STUDY DRUG HAS BEEN SHIPPED, WHICHEVER OCCURS FIRST.ACCEPTED AND AGREED:FOR PFIZER CENTRAL RESEARCH:_____________________ ______ ______________________Signature Date ClinicianFOR:«Institution»«InvestigatorName»____________________________ _______ _____________________Signature (Investigator) Date Title____________________________ _______ ______________________Signature (For the Institution) Date TitlePrint Name and Title___________________________________________________________Version 1 – 3/12/01

July 25, 2002#xxxxx-«InvestigatorNumber»ATTACHMENT APer Subject Cost: «PerPatientAmt»It is agreed that payment of the sums due under this agreement shall be made payable to:1. “The Trustees of the University of Pennsylvania” and will reference this Agreement number and thePrincipal Investigator’s name and will be sent to:Research ServicesUniversity of Pennsylvania133 South 36 th StreetMezzaninePhiladelphia, PA 19104-3246Attention: Executive Director23-1352686Institution Tax Identification NumberPayment Schedule: The first payment in the amount of «FirstPayment» will be made within one month ofdrug shipment. Subsequent payments will be calculated and paid based upon quarterly review of subjectdata received. Screen Failures will be paid based upon procedures completed. OR Screen Failures willbe paid a fixed rate of $ per patient, and are inclusive of overhead.*The quarter is defined as approximately three months after the overall study’s first payment is issued,and every three months thereafter.If the terms per the statement of agreement and this attachment are acceptable by you please so indicateby signing and returning this attachment.ACCEPTED AND AGREED:FOR PFIZER CENTRAL RESEARCH__________________________________________ .Version 1 – 3/12/01

Signature Date ClinicianFOR:«Institution»«InvestigatorName»__________________________ _________________ «InvestigatorName»Signature Date Principal Investigator____________________________________________(Signature for the Institution)Date«Institution»Print Name and TitleVersion 1 – 3/12/01