RECORDKEEPING, REPORTING AND ACCESS Clause Samples

RECORDKEEPING, REPORTING AND ACCESS. A. UNC-CH's authorized representative(s), representatives of the Bill & Melinda Gates Foundation, and regulatory authorities t▇ ▇▇e extent ▇▇▇▇▇▇▇ed by law, may, during regular business hours, arrange in advance with Immtech's Principal Investigator and Immtech to: (1) examine and inspect Immtech's facilities required for performance of the Research; and (2) inspect and copy all data and work products relating to the Research (such copying to be done at the expense of the requesting party if more than one copy is requested to be made). B. Immtech shall cooperate with any regulatory authority and allow regulators access to applicable records and data. In performing the Research, Immtech shall abide by the guidelines for biomedical research set forth by the Council for International Organizations of Medical Sciences.

RECORDKEEPING, REPORTING AND ACCESS. The Sponsor's authorized representative(s) may, during regular business hours upon advance written notice: examine and inspect the University's facilities required for performance of the Research; and inspect and copy all data and work products relating to the Research in accordance with applicable law. University shall cooperate with any regulatory authority and allow them access to applicable records and data in accordance with applicable law. The University and the Principal Investigator shall perform the following recordkeeping and reporting obligations: preparation and maintenance of written records, accounts, notes, reports and data of the Research; preparation of all original case report forms (“CRFs”) for each human patient or subject participating in the Research (“Research Subject”) to the extent required by the Protocol; and deliver to Sponsor all original CRFs to the extent required by the Protocol, and in no event later than thirty (30) business days after the date of termination of the Agreement. [Optional] preparation of a final written report (“Final Report”) including a complete summary of the Research in the form and format specified by the Sponsor. The Final Report will be submitted to the Sponsor as promptly as practicable following completion of the last CRF. Sponsor shall pay the University up to a total sum of $  based upon $  per completed, evaluable CRF. The total sum assumes enrollment of   (number) evaluable Research Subjects in accordance with the Protocol. The payment noted above includes all applicable overhead. Payment shall be made to the University as stated in Exhibit B incorporated herein by reference, unless otherwise agreed in writing by the Parties. Checks will be made payable to: The Board of Trustees of the University of Illinois. Checks will reference this Agreement number and the account name and will be sent to: University of Illinois at Chicago – Grants and Contracts ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇ Partial payment for Research Subject(s) who do not complete the Protocol and/or are lost to follow up will be made in accordance with Exhibit C incorporated herein by reference. Sponsor shall pay the University the total sum of $  as set forth in the budget attached as Exhibit B incorporated herein by reference. Payment includes all applicable overhead. The University reserves the right to re-allocate funds between budget categories.

RECORDKEEPING, REPORTING AND ACCESS. A. The Institution shall notify Sponsor of each serious adverse event encountered in the Clinical Trial within twenty-four (24) hours of becoming aware of it. B. The Institution shall, in a timely manner, prepare and maintain complete and accurate written records related to the Clinical Trial (“Records”). D. The Institution will provide the Sponsor with quarterly updates concerning the progress of the Clinical Trial. Upon completion of Clinical Trial, or earlier termination of this Agreement, the Institution will provide a final written report (“Final Report”) to Sponsor describing the outcomes of the work performed.

RECORDKEEPING, REPORTING AND ACCESS. A. Sponsor’s authorized representatives and governmental and regulatory authorities, to the extent permitted by law, may, during regular business hours, arrange in writing in advance with CPS to inspect the facilities CPS will use to provide the Services. B. If CPS or Sponsor becomes aware of the occurrence of any unexpected event which may have an effect on the validity of any of the Services provided by CPS under this Agreement, then the party becoming aware of the unexpected event shall notify the other party, in writing, of the occurrence of the unexpected event. The notice will be made within forty-eight (48) hours (or earlier if required by law) after the party learns of the occurrence the unexpected event. The party which becomes aware of the unexpected event shall document, to the best of its ability based on the information available to it, the nature and cause of the unexpected event and both parties shall document, in writing, any actions they may take as a result of the unexpected event. C. During the term of this Agreement, CPS will promptly notify Sponsor by telephone and, subsequently, in writing, of any material changes that may effect the provision of Services by CPS under this Agreement, including, but not limited to, changes in personnel involved in providing the Services on behalf of CPS. D. If any governmental or regulatory authority conducts or gives notice to CPS of its intent to conduct an inspection of CPS’s facilities and/or records or to take any other regulatory action with respect to the Services, then CPS will, to the extent permitted by applicable law and regulation: (i) promptly give Sponsor notice thereof; and (ii) send to Sponsor all information and copies of relevant documents received by CPS from the governmental or regulatory agency related thereto. To the extent required by law or applicable regulation, CPS shall permit inspection of CPS’s facilities and of such information, data and materials requested by the governmental or regulatory authority. To the extent permitted by law or applicable regulation, CPS shall: (1) make reasonable efforts to confer with Sponsor and to agree with Sponsor on a response to the governmental or regulatory agency; (2) provide Sponsor with copies of all notices and related correspondence from governmental and regulatory authorities and any regulatory inspection reports; and (3) permit Sponsor representatives to attend any inspections by governmental or regulatory authorities. E. CPS shall ...

RECORDKEEPING, REPORTING AND ACCESS. A. Subject to the confidentiality provisions contained in Section 6 below, UNC-CH's authorized representative(s), representatives of the Foundation, and regulatory authorities to the extent permitted by law, may, during regular business hours, arrange in advance with Immtech's Principal Investigator and Immtech to: (1) examine and inspect Immtech's facilities, including labs and trial sites required for performance of the Research; and (2) inspect and copy all data and work products relating to the Research (such copying to be done at the expense of the requesting party if more than one copy is requested to be made). B. Immtech shall cooperate with any regulatory authority and allow regulators access to applicable records and data, including records, accounts, notes, reports and data prepared and maintained pursuant to clause 4.C below. In performing the Research, Immtech shall abide by the guidelines for biomedical research set forth by the Council for International Organizations of Medical Sciences. C. Immtech and its Principal Investigator shall perform the following record keeping and reporting obligations in a timely fashion: (1) preparation and maintenance of complete, accurately written records, accounts, notes, reports and data of the Research; and (2) preparation and submission to UNC-CH in a timely manner of a copy of all original case report forms ("Case Reports") for each patient or subject participating in the Research ("Research Subject") as provided in the Protocols. D. All data and work products relating to the Research, including data and work products developed by subcontractors, shall be jointly owned by UNC-CH and Immtech; provided, however, that Immtech may use the data and work products generated by the Research in connection with efforts to obtain regulatory approval for Immtech products.

RECORDKEEPING, REPORTING AND ACCESS. A. The Sponsor's authorized representative(s), and regulatory authorities to the extent required by law, may, during regular business hours, arrange in advance with the Principal Investigator and Institution to: (1.) examine and inspect the Institution's facilities required for performance of the Research; and (2.) inspect and copy all data and work products relating to the Research. B. Institution shall cooperate with any regulatory authority and allow them access to applicable records and data. C. The Institution and the Principal Investigator shall perform the following recordkeeping and reporting obligations in a timely fashion: (1.) preparation and maintenance of complete, accurately written records, accounts, notes, reports and data of the Research; (2.) preparation and submission to Sponsor of all original case report forms ("Case Reports") for each patient or subject participating in the Research ("Research Subject") as provided in the Protocol; and (3.) All Case Reports will be delivered to Sponsor by Institution in a timely manner throughout the performance of Study, and in no event later than ten (10) working days after the date of termination of the Agreement or on which Sponsor reasonably requests delivery of data. (4.) [OPTIONAL] Preparation of a final written report ("Final Report") including a complete summary of the study acceptable to the Sponsor. The Final Report will be submitted to the Sponsor promptly following completion of the Research, with the last Case Reports. C. All data and Case Reports relating to the Research shall be owned by the Sponsor and the Institution. The Sponsor may use or transfer the same for any lawful purpose in a manner not inconsistent with this Agreement with no further payment to the Institution. The Institution may use the data it generates hereunder in accordance with this Agreement and for the educational and research purposes of a university. The Sponsor may transfer its ownership rights; the Institution's ownership rights cannot be transferred and cannot be used to transfer title to the data.

RECORDKEEPING, REPORTING AND ACCESS. 4.1. The Sponsor's authorized representative(s), and regulatory authorities to the extent required by law, may, during regular business hours, arrange in advance with the Research Organization to: 4.1.1 Examine and inspect the Research Organization's facilities required for performance of the Research; and

RECORDKEEPING, REPORTING AND ACCESS. Research results and associated data contained in the Case Report Forms (CRF) and research reports generated pursuant to the Protocol shall be the property of the Sponsor, provided that Facility will be free to use the research results and associated data generated for any reasonable purpose, including non-commercial research, educational and patient care purposes. Sponsor may utilize all data and results as permitted by subjects’ signed informed consent and HIPAA authorization forms. Facility shall cooperate with any regulatory authority with appropriate jurisdiction and allow said authorities reasonable access to relevant study records and data maintained at Facility. If Sponsor requests that the Facility retain records for a period longer than U.S. laws or regulations require, Sponsor may be required to (i) pay for the continued storage of Study records by the Facility, or (ii) pay for costs associated with shipping such records to Sponsor. Sponsor shall respond promptly to the Facility’s requests regarding record disposition. Facility shall not destroy such records without giving Sponsor prior written notice. Sponsor shall promptly report to Facility, at the address referenced in the Notices section below, any findings from monitoring or safety reporting of the Study that could (i) affect the safety of Study subjects, (ii) affect the Study subjects’ willingness to continue participation in the Study, (iii) influence the conduct of research, or (iv) alter the IRB’s approval to continue the Study. In addition, Sponsor and Facility shall immediately notify each other of any aspects of the Protocol, including any unanticipated problems that pose risks to subjects or that may adversely affect the safety, well-being or medical care of subjects. Authorized representatives of Sponsor, upon reasonable advance notice and during regular business hours, shall have the right, to the extent allowed by applicable law, and Facility’s policies pertaining to patient confidentiality, to inspect portions of the Facility used in the conduct of the Study and to inspect and copy records relating to the Study (including, without limitation, access to records as necessary for study monitoring or to audit the conduct of the Study in accordance with Sponsor standards).

RECORDKEEPING, REPORTING AND ACCESS